Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

NCT03832478 | Withdrawn DMC

• 1 other identifier: 46879
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety; Pain; Pain, Postoperative

Keywords

Virtual Reality; Meditation; Mindfulness Meditation; Guided Mindfulness Meditation; Anxiety; Pain; Postoperative pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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)

• 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.

Study Arms (1)

Virtual Reality Headset Given

EXPERIMENTAL

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

Interventions

Virtual Reality Headset Given DEVICE

Samsung Gear VR Headset with guided mindfulness meditation app

Virtual Reality Headset Given

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Stanford Pediatric Surgery Clinic

Palo Alto, California, 94304, United States

Location

Related Publications (5)

• 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.

  PMID: 21779307 BACKGROUND

• 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.

  PMID: 28644422 BACKGROUND

• 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.

  PMID: 19853530 BACKGROUND

• 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.

  PMID: 16882820 BACKGROUND

• 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.

  PMID: 25561079 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Stephanie D Chao, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery (Pediatric Surgery)

Model Details: Prospective observational study

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 6, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)