Medical Mindfulness: Virtual Reality Mindfulness Therapy... | NCT03745833

Studies
Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders

NCT03745833

Sponsor

Stanford University

Status

Unknown status

Last Update Posted

Nov 19, 2018Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Eating Disorder
Anxiety
Abdominal Pain

Interventions

Virtual Reality Mindfulness

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2019Estimated

Primary Completion Date

Apr 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Nov 13, 2018

First Submission Date that Met QC Criteria

Nov 15, 2018

First Posted Date

Nov 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2018

Last Update Posted Date

Nov 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Participants will be shown a brief VR-based mindfulness intervention after meals.	Device: Virtual Reality Mindfulness

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Reality Mindfulness	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients admitted to the inpatient medical unit for refeeding for malnutrition

Exclusion Criteria:

non-English speakers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Megen Vo, MD	Contact	5182218601		megenvo@stanford.edu
Colleen Surmay, NP	Contact	6509884106		csurmay@stanfordchildrens.org

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001068	Feeding and Eating Disorders
D001008	Anxiety Disorders
D015746	Abdominal Pain

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided