Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

Not Applicable

Withdrawn

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Virtual Reality Headset Given	Virtual Reality Headset Given	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.

Primary Outcome Measures

Name	Time	Method
Change in Children's Fear Scale	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)	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.
Change in Faces Pain Scale	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)	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.
Change in Anxiety Scale	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)	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.

Secondary Outcome Measures

Name	Time	Method
Clinician Satisfaction Surveys	Satisfaction survey will be administered to physicians within 48 hours of procedure completion. Physicians may return surveys up to one month post-procedure.	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 .
Patient and Parent Satisfaction Surveys	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)	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 .

Locations (2): Lucile Packard Children's Hospital
🇺🇸
Palo Alto, California, United States
Stanford Pediatric Surgery Clinic
🇺🇸
Palo Alto, California, United States