Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders

NCT ID: NCT03745833

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2019-09-30

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.

Conditions

Eating Disorder; Anxiety; Abdominal Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Virtual Reality Mindfulness

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• non-English speakers

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Megen Vo

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Megen Vo, MD

Role: CONTACT

megenvo@stanford.edu

5182218601

Colleen Surmay, NP

Role: CONTACT

csurmay@stanfordchildrens.org

6509884106

Other Identifiers

47146

Identifier Type: -

Identifier Source: org_study_id