Eating DisorderNCT03745833
Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders
A study testing Virtual Reality Mindfulness in people with Eating Disorder and Anxiety, run by Stanford University.
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. Read more about this study
- Who is it for?
- Ages 11 to 25 years
- Conditions the study is for
- Eating Disorder, Anxiety, Abdominal Pain
- What is being tested?
- Virtual Reality Mindfulness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients admitted to the inpatient medical unit for refeeding for malnutrition
Who cannot join
- non-English speakers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Virtual Reality Mindfulness
- Medical subject headings
- Feeding and Eating Disorders, Anxiety Disorders, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality MindfulnessDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be shown a brief VR-based mindfulness intervention after meals. Receives: Device: Virtual Reality Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain
We will measure pre- and post-intervention pain scores using the validated Faces Pain Scale
Measured: 1 hour after meals
Secondary outcomes (1)
Anxiety
We will measure pre- and post-intervention anxiety scores using the validated Hamilton Anxiety Scale
Measured: 1 hour after meals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study startJan 2019 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megen Vo, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745833
- Sponsor's protocol ID
- 47146
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Adolescent and Young Adult Patients With Eating Disorders
- ClinicalTrials.gov ID
- NCT03745833
- Acronym / sponsor ID
- 47146
- Conditions
- Eating Disorder, Anxiety, Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Virtual Reality MindfulnessParticipants will be shown a brief VR-based mindfulness intervention after meals. |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients admitted to the inpatient medical unit for refeeding for malnutrition
Key exclusion criteria (1 listed)
- non-English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality MindfulnessParticipating 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. | Device | Intervention |
Primary outcome
Abdominal pain
Time frame: 1 hour after meals
We will measure pre- and post-intervention pain scores using the validated Faces Pain Scale
1 secondary outcome
Anxiety
Time frame: 1 hour after meals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Mindfulness in people with Eating Disorder and Anxiety, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megen Vo, MD (5182218601, megenvo@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal pain (time frame: 1 hour after meals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.