Pilot Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care During Pediatric Laceration Repair

Abstract

Virtual reality (VR) is an emerging immersive technology with initial documentation of reduction in anxiety and pain when used by children in the hospital setting. The objective of this study was to compare VR to standard of care (SOC) in a pediatric Emergency Department (ED) for pain management and anxiety among children needing a laceration repair procedure. We conducted a prospective randomized controlled trial in a tertiary pediatric ED (NCT03681717) with children 6–16 years of age going through a laceration repair procedure. Intervention was low-cost VR goggles with a free roller coaster application during the procedure or SOC in the ED during the same time (1:1). The primary outcome was post-procedure pain (Faces Pain Scale – Revised (FPS-R)), and secondary outcome was the Venham Situational Anxiety (VSA) score. A total of 32 subjects were in the VR group and 30 in the SOC group. Age, gender, location and length of the laceration, number of sutures needed, use of oral, topical or local anesthetics, time to complete the procedure and time to discharge, were similar between groups. Pain and anxiety as measured after the procedure were very low, and similar between groups. Children rated the VR experience more positively than the SOC (p = 0.01). Using low cost VR system was similar to our tertiary pediatric center SOC comfort level and children enjoyed the VR system more. VR may serve as an additional tool in the armamentarium of ED providers for pain and anxiety reduction during laceration repairs.

Introduction

Virtual Reality (VR) creates a 3-dimensional artificial environment that involves visual, auditory and proprioceptive senses and was shown to lead to distraction and attention, emotional and concentration changes during painful medical procedures, and subsequently reduce the perception of pain (Gold et al. 2007).

Laceration repair is one of the most common emergency department (ED) procedures, and may require the use of needles for administration of local anesthetics in non-sedated patients (Fein et al. 2012). Furthermore, children may feel anxious while undergoing a laceration repair so comfort measures and distraction techniques help children to cope (Lambert and Goldman 2018).

We aimed to determine if VR can serve as an adjunct to standard pain management and reduce pain and anxiety in children during a laceration repair in the ED.

Methods

This was a prospective randomized controlled trial conducted in a tertiary pediatric ED in Vancouver, Canada (ClinicalTrials.gov –NCT03681717). Children were recruited from February to October 2018 and the study was approved by the Institutional Review Board. Included were children 6–16 years of age arriving to the ED with a laceration, that according to the physician had to be repaired with suturing. Children with facial lacerations in the area covered by the VR goggles were excluded. Parents reviewed and signed an informed consent and children 7–16 read and signed an informed assent.

A research assistant (RA) demonstrated the VR system after which children had a 30 s exposure-trial as part of the consent process. They were then randomized in a 1:1 ratio to an intervention arm (VR goggles), or a comparator arm (standard of care – available distraction tools such as watching TV, listening to music, a tablet or smartphone available for children, and a registered child life specialist). Randomization (in blocks of 4) was achieved using sealed opaque envelopes that were opened sequentially once consent and assent were obtained. Envelopes were prepared by staff not directly involved in the study using a computerized randomization table. Ten trained RAs were responsible for enrolling patients and assignment to allocated study arms.

VR System

Children in the intervention arm were provided with a VR Headset (ReTrak Utopia 360 VR Headset) and smartphone (Asus Zenfone 2 ZE551ML) pre-loaded with a VR Roller Coaster app (VR Roller Coaster, Frag). The cost of the system included $20 head-set goggles, $200 mobile phone and a free downloaded software.

Study Procedure

Once consent and assent were obtained and participants randomized, they completed a short questionnaire including demographic information. Children in the VR arm were given the VR headset immediately prior to the beginning of the procedure (injection of local anesthetic). Children in the comparator arm started their intervention at the same time. Topical and local anesthetics were allowed for the procedures, used at the ED physician’s discretion and amounts were recorded. After completion of the procedure, children responded to validated questionnaires on pain and anxiety. Children in both study arms were offered the opportunity to play with the VR system for 15 min after the procedure.

Outcome Measures

The primary outcome was post-procedure pain, as measured using the validated Faces Pain Scale – Revised (FPS-R), (www.iasp-pain.org). Children were read a scripted question and selected one of six faces (scored 0,2,4,6,8,10).

Secondary measures included the post-procedure level of anxiety as measured by the validated Venham Situational Anxiety (VSA) score (a series of 8 pairs of line drawings, each pair including an anxious and non-anxious depiction). Children selected the picture that best represented their level of anxiety.

Additional outcomes included the length of the time the procedure took, as well as length of time in the ED, amount of anesthetic used as well as patients and parents satisfaction from the intervention. Length of the procedure was calculated as time from start of administration of local anesthetic to the time when no further contact with the patient was required. Medications administered prior to, and during the procedure were recorded after discussion with the patient or their parents. Patient satisfaction was recorded as a qualitative comment that was differentiated into negative, neutral or positive comment after the database was complete.

Power and Statistical Analyses

Sample size calculation was based on a beta error rate of 20% (power of 80%), an alpha error rate of 5%, a clinically meaningful reduction in pain of 2 on the FPS-R scale, a median score of 5 and a standard deviation of 1. We estimated the effect size of the intervention to be 0.7 The calculated sample size was 32 subjects in each group.

Authors had full access to the data and were responsible for maintaining its integrity. All cases were managed with intention to treat. Data was collected on a Microsoft Excel spreadsheet and analyzed using R version 3.5.1. A p value less than 0.05 was considered statistically significant.

Basic descriptive statistics and frequencies were used to describe all variables, comparing demographic and procedure data. We compared between children on the VR (intervention) vs SOC group using a univariate analyses. We used independent t-test to compare continuous variables, and Chi-square or Fisher’s exact test for categorical variables.

Results

We screened 146 patients, 72 were offered to participate and a total of 10 were excluded because the physician eventually decided not to suture (5, 7%); they changed their mind (2, 3%); or for other reasons (3, 4%). A total of 32 subjects were in the VR group and 30 in the SOC group. Mean age (standard deviation) was 122 (39.5) months, length of laceration 3 (SD 2) cm and number of sutures 5.7 (3.3). Procedure time was a mean of 27.4 (19.2) minutes and length of time between end of procedure and discharge home was 15.2 (22.8) minutes. Mean pain after the procedure, our main outcome measure, was 1.7 (2.0)/10 and anxiety level after the procedure was 1.5 (1.9)/10. Procedural sedation was eventually needed in 2 children in the VR and 4 in the SOC groups.

Comparison between VR and SOC groups is presented in Table 1. Age, gender, body part, length of laceration, number of sutures, use of oral, topical or local anesthetics, time to complete the procedure and time to discharge were similar between groups.

Table 1.

Patient Characteristics and Comparison between Groups (VR = Virtual Reality; SOC = Standard of care; SD=Standard Deviation)

	VR N = 32	SOC N = 30	P value
Mean Age (month) (SD)	118 (38.3)	125 (41.0)	0.486
Gender Male (N, %)	19 (59)	20 (66)	0.553
Location of Laceration (N, %)			0.517
Digit	4 (12.5)	8 (26.7)
Face	10 (31.2)	7 (23.3)
Limb	7 (21.9)	7 (23.3)
Other	11 (34.4)	8 (26.7)
Mean laceration length (cm) (SD)	3.08 (1.99)	2.94 (1.98)	0.783
Oral analgesia given (N, %)	11 (34)	7 (23)	0.498
Topical analgesia applied (N, %)	27 (84)	28 (93)	0.427
Local analgesia injected (N, %)	16 (50)	17 (57)	0.786
Mean number of sutures (SD)	5.71 (3.57	5.63 (2.99)	0.928
Mean procedure time (minutes) (SD)	29.8 (21.8)	24.8 (16.0)	0.308
Mean time from end of procedure to discharge (SD)	12.6 (15.2)	18.4 (29.5)	0.361
STUDY OUTCOMES
Mean pain post procedure [SD]	1.84 (1.94)	1.47 (2.03)	0.458
Mean anxiety post procedure [SD]	1.50 (1.81)	1.57 (1.94)	0.890
Child’s Comments			0.010
Negative	4 (12.5)	2 (6.9)
Neutral	17 (53.1)	6 (20.7)
Positive	11 (34.4)	21 (72.4)
Parent’s Comments			0.471
Negative	1 (3.12)	0
Neutral	10 (31.2)	6 (21.4)
Positive	21 (65.6)	22 (78.6)

Pain and anxiety as measured after the procedure were very low, and similar between groups. Children rated the VR experience more positively than the SOC, and rate of positive/negative parents’ comments were similar between groups.

Discussion

We found VR to provide a similar effect as SOC for post-procedure pain and anxiety as reported by children 6–16 during a laceration repair procedure in the ED at our tertiary medical center. Children liked the VR experience more than other options used (books, TV, games, iPAD, parents’ comfort etc.). It is likely that the novelty of the VR system enhanced their experience and resulted in positive feedback by the children. VR has been previously shown to reduce pain by distracting participant’s attention from the source of pain. The immersive experience was also documented to reduce anxiety, through interaction with the virtual environment (Arane et al. 2017; Bowman and McMahan 2007; Jeffs et al. 2014). Functional magnetic resonance imaging (fMRI) demonstrated reduced activity by more than half in five pain-associated areas of the brain when VR was used during painful stimulus Arane et al. 2017).

Our population in both groups were similar in age, gender, length of laceration, number of sutures and time of procedure. All patients reported very low levels of pain and anxiety after the procedure was complete, suggesting the staff in the ED produced suitable analgesia and comfort for children, using analgesics (oral, local, and topical) as well as distraction during the procedure. In the last decade our tertiary center implemented numerous programs to enhance pain assessment and management modalities as well as anxiety support,, which seems effective as reported by the children. The use of VR during the procedure provided similar level of comfort as other modalities, and should be considered as an additional tool in the hands of physicians, nurses and child life specialists.

Our findings are similar to a recent randomized controlled trial (RCT) we conducted on the use of VR versus SOC for intravenous catheter in the ED (Goldman and Behboudi 2020), and both are contrary to other findings (Caruso et al. 2020; Litwin et al. 2020; McCahill et al. 2020). Differences may be due to variability in quality of methodology used, the population included in trials, alternatives to VR (what is the SOC in the institution or procedure evaluated) and the quality of the VR system used. To ensure generalizability of our intervention, we used a very low cost goggles and a free software application. Further research should determine if VR with higher graphics and sound capabilities may further capture the attention of children and help reduce pain and anxiety.

Limitations

In our center there are numerous options for SOC, which may differ from less prosperous settings or where fewer providers are available to assist during suturing lacerations in children. We did not measure levels of pain and anxiety before or during the procedure, and the single point of measurement after the procedure may have biased the findings towards lower levels. Future research should measure change in anxiety pre- and post-procedure, as well as pain during the procedure.

Conclusion

Despite novelty and positive experience as perceived by children using VR, we did not find lower pain or anxiety post procedure in using VR compared to SOC. EDs should consider offering VR to patients during laceration repair procedures as an additional tool for comfort and support during the procedure.

Declarations

Conflict of Interest

On behalf of all authors, the corresponding author states that there is no conflict of interest.