Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedNovember 19, 2018
November 1, 2018
3 months
November 13, 2018
November 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Abdominal pain
We will measure pre- and post-intervention pain scores using the validated Faces Pain Scale
1 hour after meals
Secondary Outcomes (1)
Anxiety
1 hour after meals
Study Arms (1)
Intervention
EXPERIMENTALParticipants will be shown a brief VR-based mindfulness intervention after meals.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients admitted to the inpatient medical unit for refeeding for malnutrition
You may not qualify if:
- non-English speakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
November 13, 2018
First Posted
November 19, 2018
Study Start
January 1, 2019
Primary Completion
April 1, 2019
Study Completion
September 1, 2019
Last Updated
November 19, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share