Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03745833
• Other study ID #: 47146
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: September 2019

Study information

• Verified date: November 2018
• Source: Stanford University
• Contact: Megen Vo, MD
• Phone: 5182218601
• Email: megenvo[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 25 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• non-English speakers

Related Conditions & MeSH terms

• Abdominal Pain
• Anxiety
• Disease
• Eating Disorder
• Feeding and Eating Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal pain	We will measure pre- and post-intervention pain scores using the validated Faces Pain Scale	1 hour after meals
Secondary	Anxiety	We will measure pre- and post-intervention anxiety scores using the validated Hamilton Anxiety Scale	1 hour after meals