VR Mindfulness: Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Patients With Acute and Chronic Pain

Sponsor
Stanford University (Other)
Overall Status
Suspended
CT.gov ID
NCT04534101
Collaborator
(none)
500
1
60
8.3

Study Details

Study Description

Brief Summary

Adults and children undergoing medical care (inpatient or outpatient) often experience pain and anxiety either as a result of their medical condition or a side effect of medical procedures. The purpose of this study is to create a registry of patients using virtual reality (VR) mindfulness therapy through different aspects of their medical care to determine if VR mindfulness therapy is more effective than the standard of care (i.e., no technology based distraction) for treating or preventing anxiety and pain in adults and children suffering from chronic pain, GI conditions where pain is a common symptom, or undergoing any painful medical procedure (i.e. IV access, blood draws, endoscopy, surgery). The anticipated primary outcome will be reduction of pain and anxiety for both acute and chronic pain.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Reality Mindfulness

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Patients With Acute and Chronic Pain
Actual Study Start Date :
Jul 10, 2018
Anticipated Primary Completion Date :
Jul 10, 2023
Anticipated Study Completion Date :
Jul 10, 2023

Arms and Interventions

Arm 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.

Behavioral: Virtual Reality Mindfulness
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.

Behavioral: Virtual Reality Mindfulness
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.

Outcome Measures

Primary Outcome Measures

  1. VR Mindfulness Acceptability [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.

  2. Anxiety Outcome [Up to 1 day (before and after VR use)]

    Collect patient report outcome data on anxiety before and after using virtual reality mindfulness meditation.

  3. Pain Outcome [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 80 Years
Sexes Eligible for Study:
All

Identify inclusion criteria.

Participants must:
  1. be between ages of 5-80 years of age

  2. have comprehension of instructions in the English language

  3. English speaking

  4. Must be able to comprehend ICF

  5. 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:
  1. Significant cognitive impairment/developmental delays

  2. Seizure Disorder

  3. history of motion sickness with virtual reality

  4. severe visual impairment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Medical Center Palo Alto California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Linda Nguyen, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Linda Nguyen, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT04534101
Other Study ID Numbers:
  • 45300
First Posted:
Sep 1, 2020
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022