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Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders

Primary Purpose

Eating Disorder, Anxiety, Abdominal Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality Mindfulness
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • non-English speakers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Participants will be shown a brief VR-based mindfulness intervention after meals.

    Outcomes

    Primary Outcome Measures

    Abdominal pain
    We will measure pre- and post-intervention pain scores using the validated Faces Pain Scale

    Secondary Outcome Measures

    Anxiety
    We will measure pre- and post-intervention anxiety scores using the validated Hamilton Anxiety Scale

    Full Information

    First Posted
    November 13, 2018
    Last Updated
    November 15, 2018
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03745833
    Brief Title
    Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders
    Official Title
    Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Adolescent and Young Adult Patients With Eating Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    September 2019 (Anticipated)

    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
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorder, Anxiety, Abdominal Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Participants will be shown a brief VR-based mindfulness intervention after meals.
    Intervention Type
    Device
    Intervention Name(s)
    Virtual Reality Mindfulness
    Intervention Description
    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 Measure Information:
    Title
    Abdominal pain
    Description
    We will measure pre- and post-intervention pain scores using the validated Faces Pain Scale
    Time Frame
    1 hour after meals
    Secondary Outcome Measure Information:
    Title
    Anxiety
    Description
    We will measure pre- and post-intervention anxiety scores using the validated Hamilton Anxiety Scale
    Time Frame
    1 hour after meals

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients admitted to the inpatient medical unit for refeeding for malnutrition Exclusion Criteria: non-English speakers
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Megen Vo, MD
    Phone
    5182218601
    Email
    megenvo@stanford.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Colleen Surmay, NP
    Phone
    6509884106
    Email
    csurmay@stanfordchildrens.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders

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