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

Suspended

• Conditions: Chronic Pain; Acute Pain
• Interventions: Behavioral: Virtual Reality Mindfulness

• Registration Number: NCT04534101
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-07-10
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-09-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-22
• Primary Completion: 2023-07-10
• Study Completion: 2023-07-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inpatient Subjects	Virtual Reality Mindfulness	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 Subjects	Virtual Reality Mindfulness	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States