Virtual Reality During Procedures in Pediatric Patients

Study Overview
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Brief Summary
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This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department.

Detailed Description
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Pediatric emergency rooms and hospitals are anxiety provoking and often painful places for pediatric patients and families. Children of all ages present to the Johns Hopkins emergency room and are admitted to the hospital for a wide range of medical conditions, many of which require medical interventions. Many of these interventions are the source of anxiety and pain, including burn debridement or dressing changes, laceration repair, or intravenous (IV) line placement. The standard of care to reduce pain and improve coping during pediatric procedures ranges from no intervention to support from child life specialists. As an adjunct to the existing methods of promoting comfort during painful procedures, non-invasive virtual reality (VR) therapy is showing promise as a means of distraction and coping with various medical procedures. The user is transported into a relaxing/distracting VR environment that diverts user's attention away from pain and anxiety. VR has demonstrated efficacy in the reduction of pain and anxiety experienced by individuals undergoing anxiety and pain inducing procedures.While there is early data from small or narrow populations that show some improvement in pain and anxiety with VR use during pediatric procedures, some studies show no improvement. No studies to date have used objective outcome measures of coping, which may be more clinically meaningful. The investigators propose to fill this gap in the literature with a randomized, controlled, un-blinded study of coping and distress between virtual reality engagement and child life support in pediatric patients undergoing painful medical procedures.

Official Title
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Virtual Reality During Procedures in Pediatric Patients

Conditions
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Virtual Reality, Pediatrics

Intervention / Treatment
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* Other: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients requiring painful or anxiety inducing procedures: Burn debridement Burn dressing change Lactation repair Intravenous (IV) line placement or phlebotomy (blood draw) Abscess incision and drainage Fracture reduction and/or cast placement Implanted central venous port placement accessing Skin biopsies Subjects ages 7 to 26 years of age (age 26 is the upper limit treated at JHCC) Ages were chosen based on that previously published in the literature on pediatric patients with VR. Exclusion Criteria: Patients with a known history of a seizure disorder. Patients with an active infection, burn, or trauma that interferes with the mask placement, and may include involvement of the periorbital skin, eyes, nasal bridge, external ear, and/or scalp or hair. Patients with Blindness. Developmental delay significant enough to interfere with the subject's ability to participate in the session, including autism spectrum disorders. Patients with active psychosis or exhibit signs of active intoxication. Known history of severe motion sickness Medical urgency (at the medical providers' discretion) Non-verbal children Children or parents/legal guardians who are non-English speakers

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, unblinded, controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Group (Study Group)<br>In this arm, patients will receive support from child life specialists plus may use virtual reality simulation goggles during a qualifying medical procedure. | Other: Virtual Reality<br>* A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.<br>* Other names: Oculus Go;|
| No Intervention: Active Control Group<br>In this arm, patients will receive standard of care with child life specialists plus distraction of the child's choosing, during a qualifying medical procedure. | |
| No Intervention: External Control (Reference Group)<br>No virtual reality and no child life specialists; no standardized or formal form of support. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-Reported Pain During the Procedure | Pain described on visual analog scale (0-10), or Wong-Faces Scale (0-10) with 0 being no pain and 10 being worst pain. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. | Baseline and Immediately post-procedure, up to 15 minutes | 
| Change in Patient-Reported Anxiety During Procedure | Patient anxiety after procedures was described on a visual analog scale (0-10). This is a scale of range 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. | Baseline and Immediately post-procedure, up to 15 minutes | 
| Change in Adult Perceived Pain During the Procedure | Perceived pain ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least pain and 10 representing the most. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. This measure was assessed in caregivers. | Baseline and Immediately post-procedure, up to 15 minutes | 
| Change in Adult Perceived Anxiety During the Procedure | The Subjective Units of Distress scale will be used to measure anxiety of subjects after procedures. This is a scale of 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers. | Baseline and Immediately post-procedure, up to 15 minutes | 
| Change in Adult's Own Anxiety During the Procedure | Anxiety ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least anxiety and 10 representing the most. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers. | Baseline and Immediately post-procedure, up to 15 minutes | 
| Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score | Coping was measured using a modified CAMPIS-SF in both patients and caregivers. CAMPIS-SF (Child-Adult Medical Procedure Interaction Scale-Short Form) is a behavior rating scale that documents distressing or coping behaviors exhibited in both children and the accompanying adult (parent/guardian). It has been validated to measure coping in children and adults during medical procedures. The CAMPIS-SF study used a 5-point Likert scale to document frequency of each code In order to account for frequency variance due to differences in procedure duration, we used a proportion-based metric validated for CAMPIS-R, and applied this to CAMPIS-SF codes. Proportions were calculated by summing the total number of an event type (e.g. child distress) and dividing by the total number of coded events (child distress plus child coping). This provided a proportion for each event type so that the proportion of child distress plus child coping events add up to 1.0 (range 0-1.0). | Immediately post-procedure, up to 15minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Procedure | Duration of procedure in minutes will be assessed for each procedure. | Immediately post-procedure, up to 20 minutes | 
| Ease of Procedure as Assessed by a Likert Scale | Ease of procedure will be assessed using a Likert scale completed by proceduralist. The Likert scale ranges from 0-10 with 0 being easy and 10 difficult. | Immediately post-procedure, up to 15 minutes | 
| Personnel Use for Immobilization | This will be assessed using number of patients requiring immobilization during procedures. | Immediately post-procedure, up to 15 minutes | 
| Number of IV or Phlebotomy Attempts | Number of IV or phlebotomy attempts until success will be counted (1 or 2+) in patients undergoing venipuncture procedures. | Immediately post-procedure, up to 15 minutes | 
| Pre-Procedure Nausea Symptoms | The number of patients reporting nausea symptoms prior to the procedure | Immediately pre-procedure (15minutes) | 
| Pre-Procedure Cybersickness Symptoms | Number of patients in the VR group reporting positive cybersickness symptoms prior to the procedure | Immediately pre-procedure (15minutes) |