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Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03832478
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Stephanie D. Chao, Stanford University

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.

Condition or disease Intervention/treatment Phase
Anxiety Pain Pain, Postoperative Device: Virtual Reality Headset Given Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective observational study
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Longitudinal Virtual Reality Use in Pediatric Surgical Procedures
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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.
Device: Virtual Reality Headset Given
Samsung Gear VR Headset with guided mindfulness meditation app




Primary Outcome Measures :
  1. Change in Children's Fear Scale [ 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) ]
    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.

  2. Change in Faces Pain Scale [ 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) ]
    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.

  3. Change in Anxiety Scale [ 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) ]
    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 :
  1. Patient and Parent Satisfaction Surveys [ 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) ]
    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 .

  2. Clinician Satisfaction Surveys [ 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. ]
    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 .



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832478


Contacts
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Contact: John R Austin, MS (949) 878-1438 jaustin5@stanford.edu

Locations
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United States, California
Lucile Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94304
Stanford Pediatric Surgery Clinic Recruiting
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Stephanie D Chao, MD Stanford University
Publications:
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Responsible Party: Stephanie D. Chao, Assistant Professor of Surgery (Pediatric Surgery), Stanford University
ClinicalTrials.gov Identifier: NCT03832478    
Other Study ID Numbers: 46879
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie D. Chao, Stanford University:
Virtual Reality
Meditation
Mindfulness Meditation
Guided Mindfulness Meditation
Anxiety
Pain
Postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms