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Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders

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. Identifier: NCT03745833
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Information provided by (Responsible Party):
Megen Vo, Stanford University

Brief Summary:
Adolescents and young adults with eating disorders undergoing refeeding on an inpatient unit often experience abdominal pain and anxiety either as a result of their medical condition or as an expected side effect of nutritional rehabilitation. The purpose of this study is to assess if VR (Virtual Reality) mindfulness therapy is more or as effective as the standard of care (supportive care such as aromatherapy, heat packs, distraction, and nausea bands) for treating and/or preventing anxiety and pain in patients with eating disorders during the re-nourishment process. The anticipated primary outcome will be reduction of abdominal pain and anxiety with utilization of this intervention.

Condition or disease Intervention/treatment Phase
Eating Disorder Anxiety Abdominal Pain Device: Virtual Reality Mindfulness Not Applicable

Detailed Description:

In this study, investigators hope to 1) assess acceptance of VR mindfulness among inpatient adolescents and young adults with eating disorders 2) assess effects of VR mindfulness on perceived abdominal pain and 3) determine the impact of VR mindfulness on anxiety scores.

This study is designed to test the feasibility, acceptability and effectiveness of VR mindfulness in patients as they undergo various medical and nutritional therapies to treat their conditions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Adolescent and Young Adult Patients With Eating Disorders
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
Participants will be shown a brief VR-based mindfulness intervention after meals.
Device: Virtual Reality Mindfulness
Participating patients will be provided with a VR headset (pre-programmed with mindfulness content) after lunch for 15 minutes with supervision while on strict bedrest. The headset will be collected following the intervention. Patients are currently provided with a post-meal survey following all meals as part of the standard of care, and will complete the survey following the lunchtime intervention.

Primary Outcome Measures :
  1. Abdominal pain [ Time Frame: 1 hour after meals ]
    We will measure pre- and post-intervention pain scores using the validated Faces Pain Scale

Secondary Outcome Measures :
  1. Anxiety [ Time Frame: 1 hour after meals ]
    We will measure pre- and post-intervention anxiety scores using the validated Hamilton Anxiety Scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   11 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients admitted to the inpatient medical unit for refeeding for malnutrition

Exclusion Criteria:

  • non-English speakers

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 identifier (NCT number): NCT03745833

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Contact: Megen Vo, MD 5182218601
Contact: Colleen Surmay, NP 6509884106

Sponsors and Collaborators
Stanford University

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Responsible Party: Megen Vo, Clinical Assistant Professor, Stanford University Identifier: NCT03745833     History of Changes
Other Study ID Numbers: 47146
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
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

Additional relevant MeSH terms:
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Feeding and Eating Disorders
Abdominal Pain
Pathologic Processes
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive