Skip to main content
PLOS One logoLink to PLOS One
. 2021 Aug 31;16(8):e0256489. doi: 10.1371/journal.pone.0256489

Virtual reality environment using a dome screen for procedural pain in young children during intravenous placement: A pilot randomized controlled trial

Ha Ni Lee 1,#, Woori Bae 2,#, Joong Wan Park 1,*, Jae Yun Jung 1, Soyun Hwang 1, Do Kyun Kim 1, Young Ho Kwak 1
Editor: P W B Nanayakkara3
PMCID: PMC8407539  PMID: 34464411

Abstract

We assessed the feasibility and potential efficacy of a virtual reality (VR) environment using a dome screen as a distraction method in young children during intravenous (IV) placement in the pediatric emergency department. This randomized controlled pilot study enrolled children aged 2 to 6 years who underwent IV placement into either the intervention group or the control group. Children in the intervention group experienced VR using a dome screen during IV placement. The child’s pain intensity was measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at four time points of IV placement: immediately after arrival to the blood collection room (base); immediately after the child laid down on the bed (preparation); when the tourniquet was applied (tourniquet); and the moment at which the needle penetrated the skin (venipuncture). The guardian’s satisfaction and rating of the child’s distress were assessed using a 5-point Likert-type questionnaire. We recruited 19 children (9 in the intervention group and 10 in the control group). Five children in the control group were excluded from the analysis because of missing video recordings (n = 3), failed first attempt at IV placement (n = 1), and the child’s refusal to lie on the bed during the procedure (n = 1). No side effects of VR were reported during the study period. Although the average FLACC scale score at each time point (preparation, tourniquet, venipuncture) was lower in the intervention group than the control group, the difference was not statistically significant (2.3, interquartile range [IQR]: 2.0–3.0; vs. 3.3, IQR: 2.7–6.7, P = 0.255). There were no statistically significant differences between the groups in the guardian’s satisfaction and anxiety or his/her rating of the child’s pain and anxiety. The guardians and emergency medical technicians reported satisfaction with the use of VR with a dome screen and considered it a useful distraction during the procedure. VR using a dome screen is a feasible distraction method for young children during IV placement. A larger clinical trial with further development of the VR environment and study process is required to adequately evaluate the efficacy of VR using a dome screen.

Introduction

Visiting the pediatric emergency department (PED) is severely stressful for children and their guardians because most children presenting to the PED are in pain or require painful procedures [1]. Needle procedures, such as venipuncture and intravenous (IV) placement, are the most common causes of pain in hospitalized children [2]. IV placement is the most common invasive procedure performed in PEDs [35]. These pain- and anxiety-causing procedures may cause psychological trauma for children, make the treatment process difficult and worsen the relationship between the guardian and medical staff [6].

Appropriate pain control is essential for improving patient management, and various analgesics and nonpharmacological strategies were studied to control pain in children in the PED [7]. Among the nonpharmacological methods, digital distraction was actively studied in recent years [8]. Virtual reality (VR), often referred to as a virtual environment, is a computer technology that enables users to view or `immerse’ themselves in an alternate world, and it is attracting attention as a digital distraction technique. VR provides a clinically important reduction in pain during various procedures, such as venipuncture, burn dressing, and lumbar puncture [916].

However, previous studies generally tested VR in school-aged children. Commercially available VR systems generally require the wearing of a head-mounted display (HMD) helmet to create a virtual space and block out the real world, which may be challenging for young children [17]. The primary age group int the PED is children younger than 6 years of age, and it is essential to test VR distraction in this age group to demonstrate its effectiveness for pain reduction in the PED [18].

Since wearing an HMD is difficult for young children, we developed a new approach of delivering VR via a dome screen. To the best of our knowledge, no study has tested whether VR distraction using a dome screen is helpful for significant pain reduction during needle procedures for young children (≤ 6 years old) in the PED. The current pilot randomized clinical trial assessed the feasibility and acceptability of VR distraction using a dome screen for young children during needle procedures in PEDs. The secondary aims were to obtain preliminary results on the efficacy of VR distraction using a dome screen and to determine the sample size needed in a future larger clinical trial.

Methods

Trial design

This study was a single-center, two-arm parallel, feasibility pilot randomized controlled trial with allocation by the date of PED visit. The institutional review board (IRB) of Seoul National University Hospital approved this study prior to its start date (IRB no. 1901-094-1005), and it was registered at cris.nih.go.kr (KCT0005691) after completion. Registration of this pilot trial was performed retrospectively because the authors were less aware of the required prospective registration for the pilot trial. The authors confirm that all ongoing and related trials for this intervention are registered.

Participants

Children visiting the PED were eligible if they were aged 2 to 6 years and underwent IV placement for diagnosis or treatment. Children were excluded from the study if they needed urgent IV placement (e.g., due to an unstable hemodynamic condition or an altered mental status), had developmental disabilities or facial anomalies that made it difficult to use the pain scale, and if their guardians had insufficient Korean language ability to understand the study protocol. Children for whom IV catheter insertion failed on the first attempt were also excluded from the study. Fig 1 shows a flowchart of this study.

Fig 1. Enrollment and randomization of participants in the study.

Fig 1

This pilot randomized controlled trial was performed at the Seoul National University Children’s Hospital (SNUCH) in Seoul, South Korea between May and September 2019. SNUCH is a tertiary academic hospital with a 315-bed capacity, and over 20,000 children visit its PED annually.

Randomization and blinding

Children were randomized to either the intervention group or the control group according to the dates of their ED visits. Children whose ED visit date was an odd number were assigned to the intervention group with VR distraction, and children whose ED visit date was an even number were assigned to the control group. Allocation concealment was impossible for the trial staff recruiting participants in this randomization method. Blinding was not feasible due to the nature of the intervention.

Interventions

Study protocol

The study protocol is illustrated in Fig 2. If the patient was eligible, trial staff explained the study and obtained written informed consent from his or her guardians. Five minutes before the emergency medical technician (EMT) started the IV placement, the child entered the blood collection room with his or her guardian, and the trial staff began video recording. By adjusting the angle of view, the dome screen was not visible in the recorded video to blind each participant’s allocation to PED staff who rated the pain scale from the recorded video. For the children assigned to the intervention group, the VR animation was projected through the dome screen within 1 minute after the child entered the blood collection room. Children in the control group were asked to lie on a bed for IV placement without VR animation via a dome screen. The EMT began IV placement according to the following sequence: Tourniquet application; venipuncture site cleansing; venipuncture; and indwelling IV cannula insertion. No local anesthetics or analgesics other than the VR intervention were applied during the procedure. The guardian was allowed to hold the child’s opposite arm for reassurance during the procedure. Video recording continued to approximately 2 minutes after venipuncture. After the participant left the blood collection room, the guardian received and completed a questionnaire about the needle procedure.

Fig 2. Study protocol.

Fig 2

VR environment using a dome screen

Our VR equipment consisted of a dome screen developed by Dome & Dome Co. and a projector (EB-G7100, EPSON, Japan) linked to a personal computer that played the animated show ‘Pororo the Little Penguin’ (Fig 3). The diameter and height of the dome screen were 1600 mm and 600 mm, respectively. The dome screen was placed at the end of the bed so the child could watch the screen while lying down during the procedure. We projected the animation onto the dome screen using the projection mapping software program MadMapper version 4.0 to provide the children with a VR environment [19]. The animation used in this study was a famous Korean animated show that primarily targets children aged 3 to 5 years. We used a free downloadable episode from the official ‘Pororo the Little Penguin’ channel on the online video sharing platform YouTube (https://www.youtube.com/watch?v=A5SZuwf0e98&t=172s). Before the start of the study period, we received approval from the production company for the use of the episode for research purposes.

Fig 3. Virtual reality environment using a dome screen in the blood collection room.

Fig 3

Outcomes

The primary outcome was the observed pain intensity during IV placement. Pain intensity was measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 4 time points during the needle procedure: immediately after arrival at the blood collection room (base); immediately after the child laid on the bed (preparation); when the tourniquet was applied (tourniquet); and when the needle penetrated the skin (venipuncture). The FLACC scale is a validated pain measure for children who cannot report pain. The 5 elements of the FLACC scale are each scored on a range from 0–2 then summed for a total score ranging from 0–10, with higher scores indicating greater pain intensity [20]. Two PED staff members who were blinded to the study protocol completed pain intensity assessments based on video recordings. The two PED staff members were blinded to each child’s allocation by setting the volume in the video recordings of both groups to zero and independently observing the video recording of the needle procedure for each child.

The secondary outcomes included the guardian’s satisfaction with the procedure and rating of their child’s distress (pain, anxiety), which were assessed using a 5-point Likert-type questionnaire after the procedure. The feasibility and acceptability of this trial were assessed by asking PED staff and EMTs who participated in the needle procedure about their satisfaction with the process of providing VR intervention to children as a distraction during the needle procedure. If they answered that they were unsatisfied with VR intervention and the study process, further details were documented. The perceived effect on the child’s distress and side effects were also documented.

Sample size

Similar to previous pilot studies on distraction methods for children during painful procedures, formal sample size calculations were not required [2123]. We aimed to recruit approximately 20 children to provide sufficient preliminary evidence of the clinical efficacy of VR as a distraction method.

Statistical methods

The baseline variables are described using appropriate summary statistics. Categorical variables are reported as frequencies and percentages. Continuous variables are reported as medians and interquartile ranges (IQRs). The FLACC scale scores at each time point and the average of the FLACC scores at 3 time points (preparation, tourniquet, and venipuncture) were compared between the intervention group and control group using the Mann-Whitney U test and the independent t-test. A between-group comparison of the guardians’ responses to the postprocedural questionnaire was performed using Fisher’s exact test. All statistical tests were performed at a significance level of 0.05 (2-sided) using STATA version 14.2 (StataCorp LP, College Station, TX, USA).

Results

During the recruitment periods, 19 children were eligible, and all of the eligible children’s guardians consented to participate in this study (Fig 1). We enrolled these 19 children (9 in the intervention group and 10 in the control group). Of the 10 children allocated to the control group, five were excluded from data analysis because of missing video recordings (n = 3), failure of IV placement on the first attempt (n = 1), and refusal to lie down during the procedure (n = 1). The analysis was performed with a total sample of 14 children.

Table 1 provides information on the baseline characteristics of the participants. The overall median age was 4.5 (interquartile range [IQR]: 3.0–5.8) years, and 28.6% were boys. Approximately 71% of the children had previous experience with venipuncture, and 84.6% of their guardians had previously observed the child’s venipuncture. There were no significant differences in baseline characteristics between the intervention and control groups.

Table 1. Baseline characteristics of the participants.

Characteristic Intervention Control Total P value
(n = 5) (n = 9) (n = 14)
Age, median (IQR), years 3 (3.0–5.0) 5 (3.0–6.0) 4.5 (3.0–5.8) 0.585
Sex, male, n (%) 0 (0.0) 4 (44.4) 4 (28.6) 0.221
Reason for PED visit, n (%) 0.258
    Disease 5 (100.0) 6 (66.7) 11 (78.6)
    Trauma 0 (0.0) 3 (33.3) 3 (21.4)
Previous venipuncture, yes, n (%) 4 (80.0) 6 (66.7) 10 (71.4) 1.000
Analgesic medication in the past 2 h, yes, n (%) 2 (40.0) 4 (44.4) 6 (42.9) 1.000
Guardian’s characteristics
    Age, median (IQR), years 38 (37.0–40.0) 39 (38.0–42.0) 38 (38.0–42.0) 0.424
    Relationship, n (%) 0.505
       Mother 5 (100.0) 7 (77.8) 12 (85.7)
       Father 0 (0.0) 2 (22.2) 2 (14.3)
    Number of children, median (IQR) 1.0 (1–2) 2 (1–3) 1.5 (1.0–2.6) 0.903
    Previous observation of the child during a procedure, yes, n (%)a 3 (75.0) 8 (88.9) 11 (84.6) 0.505

PED, pediatric emergency department; IQR, interquartile range.

a One child in the intervention group was excluded from the analysis because of missing data.

Table 2 presents a comparison of the FLACC scale scores between the two groups. There was no significant difference in the FLACC scale at any time point during the needle procedure. The median FLACC scale at the time of venipuncture was 3.0 (IQR: 3.0–5.0) in the intervention group and 4.0 (IQR: 3.0–8.0) in the control group (p = 0.545). Although the average FLACC score at the 3 time points (preparation, tourniquet, venipuncture) in the intervention group was lower than the control group, the difference was not statistically significant (median 2.3 (IQR: 2.0–3.0) vs. 3.0 (IQR: 3.0 (IQR 2.7–6.7)), p = 0.255).

Table 2. Pain assessed using the FLACC scale in the intervention and control groups.

Group P valuea
Intervention (n = 5) Control (n = 9)
Base
    Mean (SD) 0.0 (0.0) 0.0 (0.0)
    Median (IQR) 0.0 (0.0–0.0) 0.0 (0.0–0.0)
    Range 0.0 to 0.0 0.0 to 0.0
Preparation 0.309
    Mean (SD) 1.6 (2.1) 3.2 (2.9)
    Median (IQR) 1.0 (0.0–2.0) 3.0 (1.0–6.0)
    Range 0.0 to 5.0 0.0 to 5.0
Tourniquet 0.139
    Mean (SD) 2.2 (1.8) 4.7 (3.3)
    Median (IQR) 2.0 (2.0–2.0) 4.0 (3.0–7.0)
    Range 0.0 to 5.0 0.0 to 5.0
Venipuncture 0.545
    Mean (SD) 3.8 (2.3) 4.8 (2.5)
    Median (IQR) 3.0 (3.0–5.0) 4.0 (3.0–8.0)
    Range 1.0 to 7.0 0.0 to 9.0
Meanb 0.255
    Mean (SD) 2.5 (1.7) 4.2 (3.1)
    Median (IQR) 2.3 (2.0–3.0) 3.0 (2.7–6.7)
    Range 0.3 to 5.0 0.0 to 8.7

FLACC, Face, Legs, Activity, Cry, Consolability; SD, standard variation; IQR, interquartile range.

a Mann-Whitney U test.

b Average scores at 3 time points (preparation, tourniquet, and venipuncture).

Based on these data in a post hoc sample size calculation (STATA version 14.2), we calculated that with 80% power and a 2-sided alpha of 0.05, a sample size of 36 per group would be required to detect possible subtle differences.

Table 3 summarizes the results of the guardians’ responses to the postprocedural questionnaire. The guardians’ ratings of the child’s pain and anxiety differed between the groups, but the difference was not statistically significant (p = 0.540 and p = 1.000, respectively). Zero percent of the guardians in the intervention group felt that their child’s experience was very painful compared with 22.2% in the control group. There were no statistically significant differences between the groups in guardian satisfaction with and anxiety for the overall procedure (p = 1.000 and p = 0.830, respectively).

Table 3. Guardian’s response to postprocedural questionnaires.

Intervention (n = 5) Control (n = 9) P value
Guardian’s rating of child’s pain
    1 (Very painful) 0 (0.0%) 2 (22.2%)
    2 1 (20.0%) 0 (0.0%)
    3 2 (40.0%) 2 (22.2%) 0.540
    4 2 (40.0%) 3 (33.3%)
    5 (Not painful) 0 (0.0%) 2 (22.2%)
Guardian’s rating of child’s anxiety
    1 (Very anxious) 0 (0.0%) 2 (22.2%)
    2 1 (20.0%) 1 (11.1%)
    3 2 (40.0%) 3 (33.3%) 1.000
    4 1 (20.0%) 2 (22.2%)
    5 (Not anxious) 1 (20.0%) 1 (11.1%)
Guardian’s anxiety during the procedure
    1 (Very anxious) 1 (20.0%) 1 (11.1%)
    2 1 (20.0%) 3 (33.3%)
    3 2 (40.0%) 4 (44.4%) 0.830
    4 1 (20.0%) 0 (0.0%)
    5 (Not anxious) 0 (0.0%) 1 (11.1%)
Guardian’s satisfaction with the overall procedure
    1 (Very dissatisfied) 0 (0.0%) 0 (0.0%)
    2 0 (0.0%) 0 (0.0%)
    3 (Neutral) 1 (20.0%) 1 (11.1%) 1.000
    4 3 (60.0%) 6 (66.6%)
    5 (Very satisfied) 1 (20.0%) 2 (22.2%)

Discussion

This pilot study showed that VR using a dome screen may be a feasible distraction method for young children during a needle procedure. It was easier than we expected to receive written consent from guardians to test the VR using a dome screen during the needle procedure. The guardians may have felt that VR using a dome screen was very unlikely to harm their child compared to a pharmacological distraction method. No side effects from VR were reported during the study period.

However, we were unable to recruit the planned number of children. Because the construction period of a PED expansion project overlapped with our study periods, we did not have adequate time to recruit children within the study periods. Approximately 15% of children were also excluded from the final analysis because of missing video recordings. Minor mistakes due to the use of unfamiliar equipment may explain the missing data, which may be reduced via sufficient practice and preparation before the start of the main study.

Because of the small number of participants, it was impossible to show a statistically meaningful efficacy of VR distraction using a dome screen. The differences in the FLACC scale between the groups were not statistically significant overall, but the children allocated to the intervention group showed a numerically smaller average score on the FLACC scale. The guardians in the intervention group also showed great satisfaction with VR using a dome screen as a distraction method in terms of its effects on their children’s pain and anxiety.

There was also not sufficient time to allow the child to concentrate on the animated show before the needle procedure. We planned the study protocol for the children to watch the VR animation for approximately 4 minutes before the EMTs entered the room, but the duration of time needed to watch the VR animation for a sufficient distraction effect was different for each child. It will be necessary to give children enough time to focus on the animated show before the needle procedure in future studies.

There were some technical issues in the implementation of VR using a dome screen in clinical practice. The child needed to tilt his or her head to watch the animated show to avoid having part of the dome screen hidden by their body or the bed. Although for the purposes of study standardization, the participants were required to lie on the bed, one child insisted on watching the animated show in a sitting position. It may be more appropriate in future studies to fix the dome screen to the ceiling or reposition it above the child’s face. Turning off the lights in the room after the animated show started also made it more difficult for the EMTs to perform the needle procedure. Although portable light was provided temporarily, the EMTs reported that it was more difficult than normal to find blood vessels to puncture.

The present study has some limitations. First, participants were randomized according to the date of their ED visit in this pilot study. We used this method for easy implementation. However, it may lead to unbalanced groups due to the high risk of selection bias. We should consider more appropriate randomization methods, such as permuted block randomization, in a future larger clinical trial to balance sample size across groups and minimize bias. Second, it was impossible to blind the children, guardians, EMTs and PED staff due to the nature of the intervention. PED staff members’ knowledge of which children were assigned to the intervention group may have affected the study process and potentially led to biased results. For the PED staff to observe the video recording, the light from the dome screen prevented blinding to whether the child was assigned to the intervention group. Using a close-up shot of the children’s face and body may help blind the PED staff reviewing video recordings to whether the animated program was playing in the room during the procedure. Third, we did not consider the effect of covariates, such as the indication for IV placement and the child’s previous experience with IV placement, on baseline pain intensity and anxiety. Fortunately, all of the children’s baseline FLACC scales were zero despite differences in baseline characteristics. Children with traumatic injuries may have greater baseline pain intensity and anxiety than children with medical diseases. Possible covariates that may affect baseline pain intensity should be considered in future studies.

Conclusion

VR using a dome screen is a feasible distraction method for young children during needle procedures and is worthy of further study. However, our preliminary results did not demonstrate meaningful efficacy because the sample size was too small to show the efficacy of VR using a dome screen. A larger clinical trial is required to investigate and confirm the efficacy of VR using a dome screen as a distraction tool for young children during IV placement. Further developments in VR equipment and study processes are also needed.

Supporting information

S1 File. Consort 2010 checklist.

(DOC)

S2 File. Dataset.

(XLSX)

S3 File. Study protocol (English version).

(DOCX)

S4 File. Study protocol (Korean version).

(DOCX)

Data Availability

All relevant data are within its Supporting Information files.

Funding Statement

This work was supported by the National Research Foundation of Korea (grant no. 2019R1C1C1011000) and Seoul National University Hospital (grant no. 04-2018-0760). The sponsors were not involved in the study design; data collection, analysis or interpretation; writing of the manuscript; or the decision to submit the manuscript for publication.

References

  • 1.Eldridge C, Kennedy R. Nonpharmacologic techniques for distress reduction during emergency medical care: a review. Clinical Pediatric Emergency Medicine. 2010;11(4):244–50. [Google Scholar]
  • 2.Walther‐Larsen S, Pedersen M, Friis S, Aagaard G, Rømsing J, Jeppesen E, et al. Pain prevalence in hospitalized children: a prospective cross‐sectional survey in four Danish university hospitals. Acta Anaesthesiologica Scandinavica. 2017;61(3):328–37. doi: 10.1111/aas.12846 [DOI] [PubMed] [Google Scholar]
  • 3.Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, et al. Pain outcomes in a US children’s hospital: a prospective cross-sectional survey. Hospital pediatrics. 2015;5(1):18–26. doi: 10.1542/hpeds.2014-0084 [DOI] [PubMed] [Google Scholar]
  • 4.Shomaker K, Dutton S, Mark M. Pain prevalence and treatment patterns in a US children’s hospital. Hospital pediatrics. 2015;5(7):363–70. doi: 10.1542/hpeds.2014-0195 [DOI] [PubMed] [Google Scholar]
  • 5.Marsh N, Webster J, Mihala G, Rickard CM. Devices and dressings to secure peripheral venous catheters to prevent complications. Cochrane Database of Systematic Reviews. 2015(6). doi: 10.1002/14651858.CD011070.pub2 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 6.Crowley MA, Storer A, Heaton K, Naccarato MK, Proehl JA, Moretz JD, et al. Emergency nursing resource: needle-related procedural pain in pediatric patients in the emergency department. Journal of Emergency Nursing. 2011;37(3):246–51. doi: 10.1016/j.jen.2011.02.013 [DOI] [PubMed] [Google Scholar]
  • 7.Bailey B, Trottier ED. Managing pediatric pain in the emergency department. Pediatric Drugs. 2016;18(4):287–301. doi: 10.1007/s40272-016-0181-5 [DOI] [PubMed] [Google Scholar]
  • 8.Aguinas H, Henle CA, Beaty JC Jr. Virtual reality technology: A new tool for personnel selection. International Journal of Selection and Assessment. 2001;9(1‐2):70–83. [Google Scholar]
  • 9.Aydın Aİ, Özyazıcıoğlu N. Using a virtual reality headset to decrease pain felt during a venipuncture procedure in children. Journal of PeriAnesthesia Nursing. 2019;34(6):1215–21. doi: 10.1016/j.jopan.2019.05.134 [DOI] [PubMed] [Google Scholar]
  • 10.Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, et al. Virtual reality for pediatric needle procedural pain: two randomized clinical trials. The Journal of pediatrics. 2019;209:160–7. e4. doi: 10.1016/j.jpeds.2019.02.034 [DOI] [PubMed] [Google Scholar]
  • 11.Dumoulin S, Bouchard S, Ellis J, Lavoie KL, Vézina M-P, Charbonneau P, et al. A randomized controlled trial on the use of virtual reality for needle-related procedures in children and adolescents in the emergency department. Games for health journal. 2019;8(4):285–93. doi: 10.1089/g4h.2018.0111 [DOI] [PubMed] [Google Scholar]
  • 12.Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. Journal for Specialists in Pediatric Nursing. 2018;23(1):e12201. doi: 10.1111/jspn.12201 [DOI] [PubMed] [Google Scholar]
  • 13.Atzori B, Hoffman HG, Vagnoli L, Patterson DR, Alhalabi W, Messeri A, et al. Virtual reality analgesia during venipuncture in pediatric patients with onco-hematological diseases. Frontiers in psychology. 2018;9:2508. doi: 10.3389/fpsyg.2018.02508 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 14.Hoffman HG, Meyer WJ III, Ramirez M, Roberts L, Seibel EJ, Atzori B, et al. Feasibility of articulated arm mounted Oculus Rift Virtual Reality goggles for adjunctive pain control during occupational therapy in pediatric burn patients. Cyberpsychology, Behavior, and Social Networking. 2014;17(6):397–401. doi: 10.1089/cyber.2014.0058 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15.Kipping B, Rodger S, Miller K, Kimble RM. Virtual reality for acute pain reduction in adolescents undergoing burn wound care: a prospective randomized controlled trial. Burns. 2012;38(5):650–7. doi: 10.1016/j.burns.2011.11.010 [DOI] [PubMed] [Google Scholar]
  • 16.Wint SS, Eshelman D, Steele J, Guzzetta CE, editors. Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. Oncology nursing forum; 2002. [DOI] [PubMed] [Google Scholar]
  • 17.Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clinical psychology review. 2010;30(8):1011–8. doi: 10.1016/j.cpr.2010.07.001 [DOI] [PubMed] [Google Scholar]
  • 18.Seo DH, Kim MJ, Kim KH, Park J, Shin DW, Kim H, et al. The characteristics of pediatric emergency department visits in Korea: An observational study analyzing Korea Health Panel data. PLoS One. 2018;13(5):e0197929. doi: 10.1371/journal.pone.0197929 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 19.Yoo H, Kim H. A study on the media arts using interactive projection mapping. Contemporary Engineering Sciences. 2014;7(23):1181–7. [Google Scholar]
  • 20.Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997;23(3):293–7. [PubMed] [Google Scholar]
  • 21.Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC medical research methodology. 2010;10(1):1. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 22.Khadra C, Ballard A, Déry J, Paquin D, Fortin J-S, Perreault I, et al. Projector-based virtual reality dome environment for procedural pain and anxiety in young children with burn injuries: a pilot study. Journal of Pain Research. 2018;11:343. doi: 10.2147/JPR.S151084 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 23.Kamsvåg T, Hedén L, von Essen L, Ljungman G. Ibuprofen in needle procedures in children with cancer—A feasibility and pilot study. Acta Paediatrica. 2020. doi: 10.1111/apa.15449 [DOI] [PubMed] [Google Scholar]

Decision Letter 0

P W B Nanayakkara

1 Jul 2021

PONE-D-21-12619

Virtual Reality Environment Using a Dome Screen for Procedural Pain in Young Children during Intravenous Placement: A Pilot Randomized Controlled Trial

PLOS ONE

Dear Dr. Park,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by 11 august 2021. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

  • A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

  • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

  • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Prof. Prabath Nanayakkara, MD, PhD, FRCP

Academic Editor

PLOS ONE

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2.  Thank you for submitting your clinical trial to PLOS ONE and for providing the name of the registry and the registration number. The information in the registry entry suggests that your trial was registered after patient recruitment began. PLOS ONE strongly encourages authors to register all trials before recruiting the first participant in a study.

As per the journal’s editorial policy, please include in the Methods section of your paper:

a) your reasons for your delay in registering this study (after enrolment of participants started);

b) confirmation that all related trials are registered by stating: “The authors confirm that all ongoing and related trials for this drug/intervention are registered”.

3. Please amend your manuscript to include your abstract after the title page.

4. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Partly

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: No

Reviewer #2: N/A

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The objective of this randomized controlled trial (RCT) is to compare children (between 2-6 years) who were given IV placements to either the intervention (virtual reality using dome screen), or control groups. The study was registered as a RCT within the Korean trial registry system (with a valid KCT #), and was approved by the respective IRB/Ethics Committee. While the study objectives sound interesting, is important, and on target, some shortcomings were observed, in regards to abiding by the CONSORT guidelines for conducting and reporting results of high-quality randomized controlled trials (RCTs). Some other (statistical) comments were also provided.

1. Methods:

Methods reporting require an orderly manner following CONSORT guidelines, without repeating information, such as Trial Design, Participant Eligibility criteria and settings, Interventions, Outcomes, sample size/power considerations, Interim analysis and stopping rules, Randomization (details on random number generation, allocation concealment, implementation), Blinding considerations should be mentioned explicitly. The authors are advised to create separate subsections for each of the possible topics (whichever necessary), and that way produce a very clear writeup. I see the Authors already made a sincere attempt; however, they are advised to write it carefully, following nice examples in the manuscript below:

https://www.sciencedirect.com/science/article/pii/S0889540619300010

Specific comments:

(a) For instance, the randomization and allocation concealment should be made very clear (they are NOT the same thing); the trial staff recruiting patients should NOT have the randomization list. Randomization should be prepared by the trial statistician, and he/she would not participate in the recruiting.

(b) The randomization scheme employed here didn't appear to be very innovative; I would like to see a published reference (in this specific direction of research), where this ED-visit date based randomization was also considered. This can, very easily, lead to unbalanced groups. On the other hand, block randomization is often recommended in (pilot) trials, to ensure a balance in sample size across groups over time.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2267325/

With the study already over, other randomizations couldn't be conducted further. However, I would like to see a clear justification on the pros and cons of this date-based randomization as a Discussion.

(c) Sample size/power: I am not necessarily agree that a sample size justification is not needed for a planning/pilot trial. See paper linked below. Can a post-hoc sample size computations be provided, so that readers have a proper idea on what they can expect, and/or what effect size the investigators wanted to base their study upon? Just choosing a number (like ~ 20 here) is not a well-thought-out science.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4876429/

(d) Statistical Analysis: Overall, looks straightforward. Not clear, what's the point of using both independent t-tests, and Mann-Whitney U tests to assess group differences, wrt the endpoints. Be specific, why both, or one of the two procedures were used.

2. Results & Conclusions:

(a) The authors should check that any statement of significance should be followed by a p-value in the entire Results section. The Results section look OK.

(b) The Conclusions section should clearly state the very pilot nature of the study, using only 14 children. The results/conclusions are "only" from this (Korean) population, and allude to future studies with higher sample sizes, and/or combining other populations to determine the differences.

Reviewer #2: I would like to thank the authors for the opportunity to review the manuscript of their pilot study evaluating the use of a VR device in young children undergoing IV placement in the ED. It is a well written manuscript of a nicely done pilot RCT on a very interesting topic, however I have some remarks and some questions.

Abstract:

As the term PED is not used elsewhere in the abstract, I’d suggest leaving this abbreviation out.

I would recommend spelling out VR fully the first time it is used in the abstract and use the abbreviation subsequently.

Manuscript

Introduction:

Do you have a reference regarding the statement that needle procedures are the most common cause of pain in hospitalized children? (page 1, line 25)

Methods:

The authors identified their study as a pilot RCT. But on the other hand they state their objective as the aim “to investigate feasibility and acceptability of VR distraction..”. In general, a feasibility study aims to assess the feasibility of the intervention and will try to define endpoints, etc. in order to assess whether a full RCT might be feasible to conduct. On the other hand, a pilot RCT mainly assesses the processes for assessing eligibility, randomization and allocation and successful follow-up. Have the authors thought of the distinction between these two terms? A helpful reference had been published in 2011 by Abbott [PMID 25082389]. I’d suggest the authors to use this reference for specifying the objectives of the current study.

The study was registered beforehand in a trial register and the definitive study design and outcomes do not seem to differ from this published study protocol, decreasing the chances of publication bias. However, questions arise whether results such as FLACC scales, satisfaction and pain scales according to care givers can be adequately assessed in a pilot RCT setting, as there is no formal sample size calculation (which can be considered normal for a pilot RCT).

The complete intervention and standard care that was delivered to both groups has been well described. I’d specifically mention whether cutaneously applied local anesthetics were allowed while placing the IV or whether these were not utilized.

Allocation of treatment was not random, but was determined by date of presentation to the ED and therefore not concealed. Treatment was obviously not blinded to the patients (children and caregivers), however the authors state that the investigators were blinded while evaluating FLACC pain scores. How was this possible with the large dome screen in place?

Is it possible to supply the readers with a picture or photograph of the experimental setup?

Discussion

The most important limitation regarding conclusions drawn from the study is the small sample size. Although the authors mention this limitation, I’d suggest emphasizing this a bit more. On page 8, could you move the sentence in line 177 [Because of the …. using a dome screen] up to the beginning of this paragraph at line 174 to underscore the lack of statistical power?

**********

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: Yes: Dr. M.L. Ridderikhof, MD PhD

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PLoS One. 2021 Aug 31;16(8):e0256489. doi: 10.1371/journal.pone.0256489.r002

Author response to Decision Letter 0


31 Jul 2021

Response to Journal Requirements

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf

Response: Thank you for your comment. We revised the manuscript to conform to the style of PLOS ONE

2. Thank you for submitting your clinical trial to PLOS ONE and for providing the name of the registry and the registration number. The information in the registry entry suggests that your trial was registered after patient recruitment began. PLOS ONE strongly encourages authors to register all trials before recruiting the first participant in a study. As per the journal’s editorial policy, please include in the Methods section of your paper:

a) your reasons for your delay in registering this study (after enrolment of participants started);

Response: Thank you for your comment. Before starting this study, we believed that registration of the trial was not necessary because it was a pilot study. Therefore, this trial was registered only after the trial was completed to meet the international guidelines. We added some sentences about the reasons for delay in registering this study in the Methods section as follows.

“The institutional review board (IRB) of Seoul National University Hospital approved this study prior to its start date (IRB no. 1901-094-1005), and it was registered at cris.nih.go.kr (KCT0005691) after completion. Registration of this pilot trial was performed retrospectively because the authors were less aware of the required prospective registration for the pilot trial.”

b) confirmation that all related trials are registered by stating: “The authors confirm that all ongoing and related trials for this drug/intervention are registered”.

Response: Thank you for your comment. We added the sentence “The authors confirm that all ongoing and related trials for this drug/intervention are registered” in the Methods section as recommended.

3. Please amend your manuscript to include your abstract after the title page.

Response: Thank you for your comment. We added our abstract after the title page.

4. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

Response: Thank you for your comment. We added captions for our supporting information files at the end of the manuscript.

Response to Reviewers’ comments

Response: We truly thank the reviewers for their thoughtful comments about our manuscript. First, we would like to inform the reviewers that some errors in our manuscript were edited. There were some mistakes during the process of typing the calculated p values, and p values in Table 3 were incorrectly stated in the Results section of the previous manuscript. We edited the p values in Table 3. The significance of the values was not changed from previous results.

Reviewer #1:

The objective of this randomized controlled trial (RCT) is to compare children (between 2-6 years) who were given IV placements to either the intervention (virtual reality using dome screen), or control groups. The study was registered as a RCT within the Korean trial registry system (with a valid KCT #), and was approved by the respective IRB/Ethics Committee. While the study objectives sound interesting, is important, and on target, some shortcomings were observed, in regards to abiding by the CONSORT guidelines for conducting and reporting results of high-quality randomized controlled trials (RCTs). Some other (statistical) comments were also provided.

1. Methods:

Methods reporting require an orderly manner following CONSORT guidelines, without repeating information, such as Trial Design, Participant Eligibility criteria and settings, Interventions, Outcomes, sample size/power considerations, Interim analysis and stopping rules, Randomization (details on random number generation, allocation concealment, implementation), Blinding considerations should be mentioned explicitly. The authors are advised to create separate subsections for each of the possible topics (whichever necessary), and that way produce a very clear write up. I see the Authors already made a sincere attempt; however, they are advised to write it carefully, following nice examples in the manuscript below:

https://www.sciencedirect.com/science/article/pii/S0889540619300010

Response: Thank you for your comment. We edited the manuscript in an orderly manner and separated subsections following CONSORT guidelines as recommended.

Specific comments:

(a) For instance, the randomization and allocation concealment should be made very clear (they are NOT the same thing); the trial staff recruiting patients should NOT have the randomization list. Randomization should be prepared by the trial statistician, and he/she would not participate in the recruiting.

Response: Thank you for your comment. Participants in this pilot RCT were randomized according to the date of their ED visit because it was easy to implement. We should have selected a randomization method that minimizes the risk of bias, but we could not use this method. However, the baseline characteristics of the study groups were similar. Allocation concealment was also impossible for the trial staff recruiting patients because of this randomization method. We should use an appropriate randomization method, such as permuted block randomization, in future larger clinical trials. We described the randomization method and blinding in the Methods section as follows.

“Children were randomized to either the intervention group or the control group according to the dates of their ED visits. Children whose ED visit date was an odd number were assigned to the intervention group with VR distraction, and children whose ED visit date was an even number were assigned to the control group. Allocation concealment was impossible for the trial staff recruiting participants in this randomization method. Blinding was not feasible due to the nature of the intervention.”

We also added some sentences about the limitations of our randomization method in the Discussion section as follows.

“We should consider more appropriate randomization methods, such as permuted block randomization, in a future larger clinical trial to balance sample size across groups and minimize bias.”

(b) The randomization scheme employed here didn't appear to be very innovative; I would like to see a published reference (in this specific direction of research), where this ED-visit date based randomization was also considered. This can, very easily, lead to unbalanced groups. On the other hand, block randomization is often recommended in (pilot) trials, to ensure a balance in sample size across groups over time.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2267325/

With the study already over, other randomizations couldn't be conducted further. However, I would like to see a clear justification on the pros and cons of this date-based randomization as a Discussion.

Response: Thank you for your comment. This randomization is not a good method, but we used it in this pilot study because of its easy implementation. A published reference is provided below, in which this ED visit date-based randomization was considered.

https://pubmed.ncbi.nlm.nih.gov/31661942/

Participants in our RCT were randomized according to the date of their ED visit. We chose this method because of its convenience in the pilot study, despite the high risk of selection bias. As we stated in the previous question, we should adopt an appropriate randomization method in a future clinical trial to minimize bias. We added some explanations about the randomization method in the Discussion section as follows.

“First, participants were randomized according to the date of their ED visit in this pilot study. We used this method for easy implementation. However, it may lead to unbalanced groups due to the high risk of selection bias. We should consider more appropriate randomization methods, such as permuted block randomization, in a future larger clinical trial to balance sample size across groups and minimize bias.”

(c) Sample size/power: I am not necessarily agree that a sample size justification is not needed for a planning/pilot trial. See paper linked below. Can post hoc sample size computations be provided so that readers have a proper idea on what they can expect and/or what effect size the investigators wanted to base their study upon? Just choosing a number (like ~ 20 here) is not a well-thought-out science.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4876429/

Response: Thank you for your comment. We performed a post hoc sample size calculation using STATA version 14.2 and added some sentences about it in the Results section as follows.

“Based on these data in a post hoc sample size calculation (STATA version 14.2), we calculated that with 80% power and a 2-sided alpha of 0.05, a sample size of 36 per group would be required to detect possible subtle differences.”

(d) Statistical Analysis: Overall, looks straightforward. Not clear, what's the point of using both independent t-tests, and Mann-Whitney U tests to assess group differences, wrt the endpoints. Be specific, why both, or one of the two procedures were used.

Response: Thank you for your comment. Due to the small sample size, we used the Mann-Whitney U test to assess the efficacy of VR intervention. P values in Table 2 were also only from the Mann-Whitney U test. Although it is not necessary from a statistical point of view to use both tests, we wanted to show the numerical differences in pain scores between the groups in various ways. We edited Table 2 to clearly show the results.

2. Results & Conclusions:

(a) The authors should check that any statement of significance should be followed by a p-value in the entire Results section. The Results section look OK.

Response: Thank you for your comment. We checked the manuscript again as recommended.

(b) The Conclusions section should clearly state the very pilot nature of the study, using only 14 children. The results/conclusions are "only" from this (Korean) population and allude to future studies with higher sample sizes and/or combining other populations to determine the differences.

Response: Thank you for your comment. We added some sentences to the Conclusion section as follows.

“VR using a dome screen is a feasible distraction method for young children during needle procedures and is worthy of further study. However, our preliminary results did not demonstrate meaningful efficacy because the sample size was too small to show the efficacy of VR using a dome screen. A larger clinical trial is required to investigate and confirm the efficacy of VR using a dome screen as a distraction tool for young children during IV placement. Further developments in VR equipment and study processes are also needed.”

Reviewer #2:

I would like to thank the authors for the opportunity to review the manuscript of their pilot study evaluating the use of a VR device in young children undergoing IV placement in the ED. It is a well written manuscript of a nicely done pilot RCT on a very interesting topic, however I have some remarks and some questions.

Abstract:

As the term PED is not used elsewhere in the abstract, I’d suggest leaving this abbreviation out.

I would recommend spelling out VR fully the first time it is used in the abstract and use the abbreviation subsequently.

Response: Thank you for your comment. We edited the abstract as recommended.

“We assessed the feasibility and potential efficacy of a virtual reality (VR) environment using a dome screen as a distraction method in young children during intravenous (IV) placement in the pediatric emergency department.”

Manuscript

Introduction:

Do you have a reference regarding the statement that needle procedures are the most common cause of pain in hospitalized children? (page 1, line 25)

Response: Thank you for your comment. We added a reference for the statement that needle procedures are the most common cause of pain in hospitalized children.

https://onlinelibrary.wiley.com/doi/full/10.1111/aas.12846

Methods:

The authors identified their study as a pilot RCT. But on the other hand they state their objective as the aim “to investigate feasibility and acceptability of VR distraction.” In general, a feasibility study aims to assess the feasibility of the intervention and will try to define endpoints, etc. in order to assess whether a full RCT might be feasible to conduct. On the other hand, a pilot RCT mainly assesses the processes for assessing eligibility, randomization and allocation and successful follow-up. Have the authors thought of the distinction between these two terms? A helpful reference had been published in 2011 by Abbott [PMID 25082389]. I’d suggest the authors to use this reference for specifying the objectives of the current study.

Response: Thank you for your comment. The objectives of this clinical trial included the properties of a pilot study and a feasibility study. We specified the objectives of the study as follows in the Introduction section.

“The current pilot randomized clinical trial assessed the feasibility and acceptability of VR distraction using a dome screen for young children during needle procedures in PEDs. The secondary aims were to obtain preliminary results on the efficacy of VR distraction using a dome screen and to determine the sample size needed in a future larger clinical trial.”

The study was registered beforehand in a trial register, and the definitive study design and outcomes do not seem to differ from this published study protocol, decreasing the chances of publication bias. However, questions arise regarding whether results such as FLACC scales, satisfaction and pain scales according to caregivers can be adequately assessed in a pilot RCT setting, as there is no formal sample size calculation (which can be considered normal for a pilot RCT).

Response: Thank you for your comment. Because of the small sample size, this preliminary result may not have demonstrated the potential efficacy of VR. We could not reach the minimum sample size of 10 per arm as planned to perform this pilot study. A larger sample with precise sample size calculation should have been required to adequately test the efficacy of the intervention. Based on the results of this pilot study in a post hoc sample size calculation, we calculated that with 80% power and a 2-sided alpha of 0.05, a sample size of 36 per group would be required to detect possible subtle differences. We added some sentences about this in the Results section as follows.

“Based on these data in a post hoc sample size calculation (STATA version 14.2), we calculated that with 80% power and a 2-sided alpha of 0.05, a sample size of 36 per group would be required to detect possible subtle differences.”

The complete intervention and standard care that was delivered to both groups has been well described. I’d specifically mention whether cutaneously applied local anesthetics were allowed while placing the IV or whether these were not utilized.

Response: Thank you for your comment. We generally do not use local anesthetics for simple needle procedures in our hospital unless there is a caregiver’s request. We added some sentences to the Methods section as follows.

“No local anesthetics or analgesics other than the VR intervention were applied during the procedure.”

Allocation of treatment was not random, but was determined by date of presentation to the ED and therefore not concealed. Treatment was obviously not blinded to the patients (children and caregivers), however the authors state that the investigators were blinded while evaluating FLACC pain scores. How was this possible with the large dome screen in place?

Is it possible to supply the readers with a picture or photograph of the experimental setup?

Response: Thank you for your comment. The photo below is a captured scene from the video recording that was used for assessing the pain scale. We recorded video by adjusting the angle of view so that the dome screen was not visible in the scene. We also tried to blind the investigators to each child’s allocation as much as possible by setting the volume to zero in the video recording of both groups. However, as we mentioned in the Discussion section, blinding was not completely achieved because of the light of VR animation and the direction of children’s gaze toward the VR animation. We added some sentences in the Methods section as follows and added the photo named “Figure 2” in the Methods section to show our experimental setup to readers.

“By adjusting the angle of view, the dome screen was not visible in the recorded video to blind each participant’s allocation to PED staff who rated the pain scale from the recorded video.”

“The two PED staff members were blinded to each child’s allocation by setting the volume in the video recordings of both groups to zero and independently observing the video recording of the needle procedure for each child.”

Discussion

The most important limitation regarding conclusions drawn from the study is the small sample size. Although the authors mention this limitation, I’d suggest emphasizing this a bit more. On page 8, could you move the sentence in line 177 [Because of the …. using a dome screen] up to the beginning of this paragraph at line 174 to underscore the lack of statistical power?

Response: Thank you for your comment. To focus the limitations of the small number of participants, the paragraph in the Discussion section was edited as follows.

“Because of the small number of participants, it was impossible to show a statistically meaningful efficacy of VR distraction using a dome screen. The differences in the FLACC scale between the groups were not statistically significant overall, but the children allocated to the intervention group showed a numerically smaller average score on the FLACC scale. The guardians in the intervention group also showed great satisfaction with VR using a dome screen as a distraction method in terms of its effects on their children’s pain and anxiety.”

Attachment

Submitted filename: Response to reviewers_dome.docx

Decision Letter 1

P W B Nanayakkara

9 Aug 2021

Virtual reality environment using a dome screen for procedural pain in young children during intravenous placement: A pilot randomized controlled trial

PONE-D-21-12619R1

Dear Dr. Sir,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Prof, P W. B. Nanayakkara, MD, PhD, FRCP

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

We are statisfied with their answers They have answered the question to the best of their ability.

Well done.

Reviewers' comments:

We are statisfied with their answers. They have answered the questions to the best of their ability.

Well done. 

Acceptance letter

P W B Nanayakkara

23 Aug 2021

PONE-D-21-12619R1

Virtual reality environment using a dome screen for procedural pain in young children during intravenous placement: A pilot randomized controlled trial

Dear Dr. Park:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. P W. B. Nanayakkara

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 File. Consort 2010 checklist.

    (DOC)

    S2 File. Dataset.

    (XLSX)

    S3 File. Study protocol (English version).

    (DOCX)

    S4 File. Study protocol (Korean version).

    (DOCX)

    Attachment

    Submitted filename: Response to reviewers_dome.docx

    Data Availability Statement

    All relevant data are within its Supporting Information files.


    Articles from PLoS ONE are provided here courtesy of PLOS

    RESOURCES