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

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ClinicalTrials.gov Identifier: NCT04534101
Recruitment Status : Active, not recruiting
First Posted : September 1, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Linda Nguyen, Stanford University

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
Acute Pain Chronic Pain 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.

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Study Type : Observational
Estimated 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 : July 10, 2018
Estimated Primary Completion Date : July 10, 2021
Estimated Study Completion Date : July 10, 2022

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Males and females age 5-80 of all ethnic backgrounds. We will enroll from GI outpatient clinics (pediatric and adult) as well as any patients who are hospitilized for acute or chronic pain as well as those who are in the preoperative room getting an IV.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534101


Locations
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United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Linda Nguyen, MD Stanford University
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Responsible Party: Linda Nguyen, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04534101    
Other Study ID Numbers: 45300
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Acute Pain
Pain
Neurologic Manifestations