- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04534101
Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Patients With Acute and Chronic Pain (VR Mindfulness)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inpatient: Inpatients will be presented with an informed consent. If they sign the consent, they will then be given a VR headset pre- programmed with content that they may use for the duration of their stay. GI patients headsets will be collected when they are discharged. There are pain and anxiety analog scales at the end of each program. This data will be downloaded to Stanford. Patient's will not be entering their PHI. we will know who has headsets, as they will be numbered. Patient who are hospitalized for chronic pain will be allowed to take the VR headset home for month and be asked to return it at their followup outpatient visit.
Outpatient: Patient's who are about to undergo gastrointestinal disease testing or be seen for an outpatient GI appointment will be presented with an informed consent. If they sign the consent, they will be given the VR headset to use prior to their procedure. There are pain and anxiety analog scales at the end of each program. This data will be downloaded to Stanford Medicine Box.Patient's will not be entering their PHI. we will know who has headsets, as they will be numbered.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
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California
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Palo Alto, California, United States, 94305
- Stanford University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Identify inclusion criteria.
Participants must:
- be between ages of 5-80 years of age
- have comprehension of instructions in the English language
- English speaking
- Must be able to comprehend ICF
- Have a medical appointment or procedure at Stanford/LPCH (inpatient or outpatient) that may cause pain or anxiety.
Identify exclusion criteria.
General Exclusion Criteria are as follows:
- Significant cognitive impairment/developmental delays
- Seizure Disorder
- history of motion sickness with virtual reality
- severe visual impairment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Inpatient Subjects
Inpatients will be presented with an informed consent.
If they sign the consent, they will then be given a VR headset pre- programmed with content that they may use for the duration of their stay.
GI patients headsets will be collected when they are discharged.
There are pain and anxiety analog scales at the end of each program.
This data will be downloaded to Stanford.
Patient's will not be entering their PHI.
we will know who has headsets, as they will be numbered.
Patient who are hospitalized for chronic pain will be allowed to take the VR headset home for month and be asked to return it at their followup outpatient visit.
|
This study is designed to test the feasibility, acceptability and effectiveness of VR mindfulness in patients as they undergo various medical therapies to treat their acute or chronic conditions.
|
Outpatient Subjects
Outpatient: Patient's who are about to undergo gastrointestinal disease testing or be seen for an outpatient GI appointment will be presented with an informed consent.
If they sign the consent, they will be given the VR headset to use prior to their procedure.
There are pain and anxiety analog scales at the end of each program.
This data will be downloaded to Stanford Medicine Box.Patient's will not be entering their PHI.
we will know who has headsets, as they will be numbered.
|
This study is designed to test the feasibility, acceptability and effectiveness of VR mindfulness in patients as they undergo various medical therapies to treat their acute or chronic conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VR Mindfulness Acceptability
Time Frame: Up to 1 day (before and after VR use)
|
Assess the acceptability of a virtual reality mindfulness meditation tool by patients who are experiencing pain, patients diagnosed with gastrointestinal disorders where pain is a common symptom, and by patients undergoing medical procedures.
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Up to 1 day (before and after VR use)
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Anxiety Outcome
Time Frame: Up to 1 day (before and after VR use)
|
Collect patient report outcome data on anxiety before and after using virtual reality mindfulness meditation.
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Up to 1 day (before and after VR use)
|
Pain Outcome
Time Frame: Up to 1 day (before and after VR use)
|
Collect patient report outcome data on pain levels before and after using virtual reality mindfulness meditation.
|
Up to 1 day (before and after VR use)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 45300
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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