Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders

November 15, 2018 updated by: Megen Vo, Stanford University

Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Adolescent and Young Adult Patients With Eating Disorders

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • non-English speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal pain
Time Frame: 1 hour after meals
We will measure pre- and post-intervention pain scores using the validated Faces Pain Scale
1 hour after meals

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 1 hour after meals
We will measure pre- and post-intervention anxiety scores using the validated Hamilton Anxiety Scale
1 hour after meals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2019

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (ACTUAL)

November 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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