Clinical trial NCT03832478: Longitudinal Virtual Reality Use in Pediatric Surgical Procedures
Official title: Longitudinal Virtual Reality Use in Pediatric Surgical Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety
Pain
Pain, Postoperative
Keywords: Virtual Reality
Meditation
Mindfulness Meditation
Guided Mindfulness Meditation
Anxiety
Pain
Postoperative pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective observational study
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Children's Fear Scale
timeFrame: 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)
measure: Change in Faces Pain Scale
timeFrame: 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)
measure: Change in Anxiety Scale
timeFrame: 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 outcomes:
measure: Patient and Parent Satisfaction Surveys
timeFrame: 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)
measure: Clinician Satisfaction Surveys
timeFrame: Satisfaction survey will be administered to physicians within 48 hours of procedure completion. Physicians may return surveys up to one month post-procedure.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Palo Alto
country: United States
facility: Stanford Pediatric Surgery Clinic
state: California
Study officials:
affiliation: Stanford University
name: Stephanie D Chao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.
citation: Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive Virtual Reality for Pediatric Pain. Children (Basel). 2017 Jun 23;4(7):52. doi: 10.3390/children4070052.
citation: Zeidan F, Gordon NS, Merchant J, Goolkasian P. The effects of brief mindfulness meditation training on experimentally induced pain. J Pain. 2010 Mar;11(3):199-209. doi: 10.1016/j.jpain.2009.07.015. Epub 2009 Oct 22.
citation: Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
citation: He HG, Zhu L, Chan SW, Liam JL, Li HC, Ko SS, Klainin-Yobas P, Wang W. Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial. J Adv Nurs. 2015 May;71(5):1032-43. doi: 10.1111/jan.12608. Epub 2015 Jan 6.