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Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

Primary Purpose

Anxiety, Pain, Pain, Postoperative

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual Reality Headset Given

About this trial

This is an interventional device feasibility trial for Anxiety focused on measuring Virtual Reality, Meditation, Mindfulness Meditation, Guided Mindfulness Meditation, Anxiety, Pain, Postoperative pain

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Lucile Packard Children's Hospital
Stanford Pediatric Surgery Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Reality Headset Given

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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 .

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 .

Full Information

NCT ID

NCT03832478

First Posted

January 23, 2019

Last Updated

March 17, 2021

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03832478

Brief Title

Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

Official Title

Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Technical difficulty with sending device home with patients

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Pain, Pain, Postoperative

Keywords

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

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective observational study

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual Reality Headset Given

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Virtual Reality Headset Given

Intervention Description

Samsung Gear VR Headset with guided mindfulness meditation app

Primary Outcome Measure Information:

Title

Change in Children's Fear Scale

Description

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.

Time Frame

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)

Title

Change in Faces Pain Scale

Description

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.

Time Frame

Title

Change in Anxiety Scale

Description

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.

Time Frame

Secondary Outcome Measure Information:

Title

Patient and Parent Satisfaction Surveys

Description

Time Frame

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)

Title

Clinician Satisfaction Surveys

Description

Time Frame

Satisfaction survey will be administered to physicians within 48 hours of procedure completion. Physicians may return surveys up to one month post-procedure.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie D Chao, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lucile Packard Children's Hospital

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Stanford Pediatric Surgery Clinic

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21779307

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.

Results Reference

background

PubMed Identifier

28644422

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.

Results Reference

background

PubMed Identifier

19853530

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.

Results Reference

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PubMed Identifier

16882820

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.

Results Reference

background

PubMed Identifier

25561079

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.

Results Reference

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Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

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