A Randomized Prospective Study Of The Use Of Ipads In Reducing Anxiety During Cast Room Procedures

Abstract

Background

Cast room procedures can be a source of anxiety for children. Various techniques, including music therapy, have been evaluated as a way to ease this anxiety. The use of iPads as a form of distraction during cast room procedures has not previously been evaluated and was the purpose of the current study.

Methods

146 children and adolescents who underwent cast room procedures during June- August 2015 were randomly assigned to one of three groups: no-iPad, iPad with video, or iPad with game. Patient heart rates were measured using a pulse oximeter in the waiting room, before the procedure, during the procedure, and after the procedure. Mean values for each group were calculated at each time interval and compared both between groups and within groups over time.

Results

There were no significant differences in baseline (waiting room) heart rate between the no-iPad and iPad groups. When compared with the no-iPad group, there was a trend toward decreased heart rate in the video group (p=0.13) and a significant increase in heart rate in the game group (p=0.026) before the procedure. There were no significant decreases in heart rate within any of the groups when comparing the waiting room heart rates with the during procedure heart rates. There was a significant difference between the no-iPad and video groups (p=0.047) when comparing the change in heart rate from baseline to before the procedure, with a decreased heart rate observed in the video group.

Conclusions

The results of this study show a significant decrease in heart rate when transitioning from the waiting room to the cast room while watching videos on the iPad. iPad-based video delivery appears to decrease anxiety prior to cast room procedures. iPad-based game play is difficult to assess as elevations in heart rate prior to the procedure are presumed to be related to game play and confound the observed effect it may have on anxiety related to the procedure.

Introduction

Cast room procedures can be a source of anxiety for children during orthopedic visits. Anxiety can make procedures difficult for both the patient and the physician, and, in extreme cases, can even be harmful to the patient.¹

Heart rate has been used in prior studies as a marker for anxiety, and increases in heart rate have been shown to correlate with anxiety, stress, and cardiac autonomic function.² In studies evaluating preoperative patients, anxiety was associated with an increase in heart rate and had negative outcomes on postoperative recovery.³,⁴ Additional studies have utilized heart rate to assess physiological anxiety during colonoscopy and cardiac catheterization.⁵,⁶

Many methods of anxiety reduction have been evaluated previously. Ear protection has been shown to decrease heart rates in children <13 years old undergoing cast removal.⁷ Our institution has previously demonstrated that music therapy effectively decreases heart rates during cast room procedures.⁸

iPads and tablets have been shown to decrease anxiety and comfort children during anesthesia induction, immunization shots, and wart cryotherapy.⁹,¹⁰,¹¹ iPad tablets were used as an alternative to oral sedatives to calm perioperative anxiety and were shown to decrease anxiety in children and increase parental satisfaction.¹² To our knowledge, the use of iPads has not yet been studied in children undergoing cast room procedures. The purpose of this randomized, prospective study was to evaluate the use of iPads as a distraction tool in effort to decrease anxiety in children during typical cast room procedures.

Methods

Institutional review board approval was obtained prior to beginning this study. Children and adolescents (aged 1-18 years) undergoing a cast room procedure (cast removal, cast placement, pin removal, fracture reduction, cast overwraps, and splint placement) were enrolled in the study over a 3-month time period from June 2015 to August 2015. Patients were recruited in the clinics of three orthopedic physicians by one of two investigators. Patients meeting inclusion criteria for age and scheduled procedure were approached in the waiting room regarding study enrollment. Two previously calibrated portable pulse oximeters were used to measure heart rate as the objective measurement of anxiety. Baseline heart rate was measured in the waiting room for one minute using 15-second intervals. Patients were then randomly assigned to one of three groups: no iPad, iPad with game, or iPad with video using a random number generator application. Patients were then transitioned to the cast room and allowed to select a video or game of their choice, based upon their group assignment. A “before procedure” heart rate reading was obtained upon entering the room, prior to starting the procedure, at 15-second intervals for a total of one minute. During the first two minutes of the procedure, patient heart rates were recorded at 15-second intervals for the “during procedure” measurements. Immediately after the procedure, heart rates were recorded at 15-second intervals for one minute as the “after procedure” recordings.

Statistical Analysis

Mean values for each portion of the visit, including waiting room (baseline), before, during, and after the procedure, were calculated. Mean values for each group were calculated at each time interval and compared both between groups and within groups over time periods. Two-tailed, two-sample t-tests were performed using Microsoft Excel (Microsoft, Redmond, WA) to assess significance.

Results

There were 146 patients enrolled in the study and randomized to the no iPad (n=47), iPad video (n=52), or iPad game (n=47) groups. Demographics for each of the groups are shown in Table I, and the procedural breakdown for each group is shown in Table II.

Table I.

Patient Demographics by Group

	No iPad	iPad with video	iPad with game
Average age (P=0.77)	8.7	9.1	8.7
Race (χ2=0.65)
African American	19	22	22
Caucasian	26	27	25
Asian/Indian	2	1	0
Middle Eastern	0	1	0
Central American	0	1	0
Sex (χ2=0.16)
Male	23	34	28
Female	25	18	19

Table II.

Procedural Breakdown by Group

Procedure	No-iPad	Video	Game	Total
Cast Removal	20	27	19	66
Cast Placement	19	17	16	52
Other Procedures
Cast overwrap	3	2	2	7
Splint placement	1	1	4	6
Fracture reduction	1	0	0	1
Joint injections	0	0	1	1
Dressing changes	1	1	1	3
Suture Removals	0	1	0	1
Aspirations	0	1	0	1
External Fixator Strut Change	1	0	0	1
Pin removals	1	1	3	5
Not specified	0	1	1	2
Total	47	52	47	146

There were no significant differences in baseline (waiting room) heart rate between the no-iPad and iPad groups (Table III). When compared with the no iPad group, there was a trend toward decreased heart rate in the video group (p=0.13) and a significant increase in heart rate in the game group (p=0.026) before the procedure. There were no significant decreases in heart rate within any of the groups when comparing the waiting room heart rate with the during procedure heart rates. There was a significant difference between the no-iPad and video groups (p=0.047) when comparing the change in heart rate from baseline to before the procedure, with a decrease of 3.3 beats/minute observed in the video group (Table IV). Heart rate before the procedure was significantly higher in the game group (p=0.026) when compared with the no-iPad group.

Table III.

Mean Heart Rate (beats per minute) by Time Period^*

	Waiting Room	Before Procedure	During Procedure	After Procedure
No iPad (N=47)	92.7	93.6	95.9	93.8
iPad with video (N=52)	93.0 (P=0.47)	89.6 (P=0.13)	94.0 (P=0.301)	93.4 (P=0.45)
iPad with game (N=47)	94.9 (P=0.28)	96.9 (P=0.026)	99.5 (P=0.19)	98.2 (P=0.088)

^*No iPad group used as reference group when calculating the p-value comparing treatment groups within each time period

Table IV.

Changes in Heart Rate (beats per minute) Between Time Periods by Procedure^*

Procedure	Study Group	Waiting Room vs.Before Procedure	Waiting room vs.During Procedure	Before vs. During Procedure	During vs. After Procedure
All procedures	No iPad	0.9	3.2	2.3	-2.2
(N=144)	iPad w Video	-3.3 (P=0.047)	1.0 (P=0.22)	4.3 (P=0.16)	-0.6 (P=0.19)
	iPad w Game	2.0 (P=0.32)	4.6 (P=0.31)	2.5 (P=0.17)	-1.3 (P=0.305)
Cast removal	No iPad	3.1	3.3	0.2	-2.9
(N=66)	iPad w Video	-4.6 (P=0.013)	1.7 (P=0.36)	6.2 (P=0.047)	-0.2 (P=0.18)
	iPad w Game	1.1 (P=0.30)	0.9 (P=0.30)	-0.2 (P=0.46)	-1.9 (P=0.36)
Cast application	No iPad	0.5	4.6	4.1	-1.3
(N=52)	iPad w Video	-1.1 (0.36)	0.1 (P=0.18)	1.1 (P=0.13)	-1.2 (P=0.49)
	iPad w Game	4.8 (P=0.14)	7.5 (P=0.26)	2.8 (P=0.27)	1.6 (P=0.105)

^*No iPad group used as reference group when calculating the p-value comparing treatment groups between time periods

Figure 1 shows the average heart rates for each of the groups during the four different time points.

Figure 1.

Trend of mean heart rate (beats/min) during each time point by treatment group.

Discussion

Cast room procedures often cause significant anxiety in children. This may interfere with the efficiency of the procedure and may result in adverse events. One of the most common cast room procedures is the removal of a cast, which requires the use of a saw. In the report by Katz et al.¹, the fluctuating level of high-frequency noise was cited as a possible cause for the anxiety reaction.

Katz studied how the use of ear protectors reduced anxiety. They found that ear protectors significantly decreased the heart rate elevation in patients undergoing plaster cast removals. Other forms of calming methods have also been studied to reduce anxiety in children during procedures. Music therapy has been one of the more popular methods. Liu et al.⁸ performed a randomized prospective study of 69 children who were assigned to cast rooms with or without lullaby music playing. In the music group, they noted lower heart rates both when entering the cast room and during the procedure when compared with baseline heart rates in the waiting room.

iPads were chosen for this study because of their popularity among children of all ages and the common use of iPads by the parents of children during these procedures. The use of video as a form of distraction was shown to reduce anxiety in children during induction of anesthesia for ambulatory surgery.⁹ The effectiveness of iPads and tablet computers at decreasing anxiety levels in children during perioperative anesthesia was shown by Seiden et al.⁷ when they demonstrated the superiority of tablet computer-based interactive distraction to oral sedating medications in decreasing patient anxiety in a randomized study of 108 patients. Parental perception of patient’s anxiety and the amount of crying from the child during immunizations and cryotherapy have also been effectively reduced with use of iPads.¹⁰ In a study by Tey et al.¹¹, a portable video player was implemented at a dermatology clinic. High anxiety levels decreased from 86% to 43% when comparing children seen during the pre-intervention group to those seen during the post-intervention period.

Our study addresses the use of iPads for anxiety in a new setting and incorporates the aspect of choice for patients in order to offer a more personalized experience. We hypothesized that iPad use would decrease anxiety in the setting and stress of cast room procedures. Previous literature for cast room procedures often catered to reduction of noise or hearing-related distractions. Our study used video, which has been successfully utilized in other specialties, and interactive games to decrease anxiety. Furthermore, similar to the study by Mifflin et al.⁹, each patient was able to choose a video or game from a pre-selected list of items. Our aim was to cater the distraction to the patient in hopes that they would remain focused on the iPad during the procedure.

Heart rate was used as an objective measurement for the assessment of anxiety in our study because of previous studies that have demonstrated positive correlation between the two variables. For instance, in a report by Kantor et al.⁸, self-reported anxiety was noted to correlate with elevations in physiological measurements of heart rate, and Smolen et al.⁵ assessed the effectiveness of music therapy on anxiety during colonoscopies through decreases in heart rate.

The results of our study demonstrated significant differences in heart rate between the waiting room and the cast room when comparing the video group to the control group. This may indicate a benefit to using iPads and tablets prior to the start of procedures. A subgroup analysis of the patients undergoing cast removal demonstrated a significant increase in heart rate in the video group when evaluating the change in heart rate during the procedure. This would suggest that the noise of the cast saw may have negated the benefits of the videos. Noise cancelling headphones could be considered in the future.

Contrary to our hypothesis, the game group showed increases in heart rate in almost all segments of the visit when compared with the control and video groups. It is believed that the excitement of playing a game elevated the heart rate and masked any potential decreases in anxiety. While a decrease in heart rate was not seen consistently across all test groups when compared to the control, physicians and orthopedic technicians subjectively noted a substantial change in the cooperation of patients. The use of iPads during cast room procedures has been implemented in our clinics since the start of this study and anecdotal differences continue to be reported. Based on these results, a study design assessing anxiety using methodologies outside of heart rate would be necessary to clarify the role of games.

Although age can be an important factor in anxiety, we did not see any clear correlations in this study even after performing multiple regression analysis with age stratification.

There were several limitations to our study. The data was collected by two investigators, which may have accounted for some differences in measurements.

However, the two investigators developed the protocol together and enrolled 77 patients together in attempts to create a uniform experience for patients. As no power analysis was performed prior to study enrollment, the role of sample size and magnitude of the effect required to demonstrate statistically significant changes remains unknown. The trend toward smaller increases in heart rates for those in the video group during and after the procedure may have shown significance with a larger sample size. In addition, while multiple anecdotal cases of decreased anxiety in both the game and video groups were seen, no formal subjective anxiety scale was used in our study.

In conclusion, watching videos on the iPad resulted in a significant decrease in heart rate when transitioning the patient from the waiting room to the cast room, and there was a trend toward lower heart rates during and after the cast removal procedure. Although not directly assessed in the current evaluation, this may represent improved patient cooperation and family member satisfaction through the use of iPad videos prior to and during cast room procedures. Further work in this area should include the investigation of additional forms of distraction and other objective measurements of anxiety as changes in heart rate are undoubtedly multifactorial and not perfect measures of anxiety.