Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

Study Overview
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Brief Summary
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This study aims to investigate the use of virtual reality guided mindfulness meditation to reduce the pre and post-operative anxiety and pain of pediatric surgical patients.

Detailed Description
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Pre-procedural anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. Post-procedural pain has been shown to negatively impact future interactions with healthcare personnel. The purpose of this study is to determine the feasibility of using guided mindfulness meditation through a non-invasive device (virtual reality headset) to manage pre-procedure anxiety and post-procedure anxiety and pain.

Official Title
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Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

Conditions
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Anxiety, Pain, Pain, Postoperative

Intervention / Treatment
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* Device: Virtual Reality Headset Given


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have parental consent if under 18 or 18 and older but unable to provide own consent Can comprehend instructions in English language Is undergoing surgical procedure requiring general anesthesia at Lucile Packard Children's Hospital Children that are normally healthy (ASA I) or have a mild systemic disease (ASA II, III) Exclusion Criteria: Children with significant cognitive impairment or developmental delays per parental report or H&P Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive >24hours or without operation) Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation Children with history of seizures related to photosensitivity.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective observational study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Headset Given<br>Virtual Reality headset (Samsung Gear VR) with mindfulness meditation app is given for patient use prior to surgery date and for duration of postoperative stay. | Device: Virtual Reality Headset Given<br>* Samsung Gear VR Headset with guided mindfulness meditation app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Children's Fear Scale | The Children's Fear Scale (McMurty et al., 2011) is a self-report scale that uses cartoon depictions of faces to quantify on a 0-4 scale how scared a child is at the given moment. | Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis) | 
| Change in Faces Pain Scale | The Faces Pain Scale (Hicks et al., 2001) is a self-report scale that uses cartoon depictions of faces to quantify on a 0-10 scale how much pain a child is experiencing at the given moment. | Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis) | 
| Change in Anxiety Scale | A self-report question on a 1-5 scale will be asked to assess how much anxiety a child is experiencing at the given moment. | Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Parent Satisfaction Surveys | Parents, and patients will be given self-report survey questions asking about their satisfaction with the technology, the patients' immersion with the technology, and desire for use in future procedures. Questions will be answered on a 1-5 scale . | Satisfaction surveys will be administered at the time of study completion (when the patient has completed his/her surgical procedure and is ready for hospital discharge/or 30 days post-procedure, whichever occurs first) | 
| Clinician Satisfaction Surveys | Surgeons and anesthesiologists will be given self-report survey questions asking about their satisfaction with the technology, the patients' immersion with the technology, and desire for use in future procedures. Questions will be answered on a 1-5 scale . | Satisfaction survey will be administered to physicians within 48 hours of procedure completion. Physicians may return surveys up to one month post-procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Meditation, Mindfulness Meditation, Guided Mindfulness Meditation, Anxiety, Pain, Postoperative pain