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

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.

Study Overview

• Status: Suspended
• Conditions: Chronic Pain; Acute Pain
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VR Mindfulness Acceptability	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.	Up to 1 day (before and after VR use)
Anxiety Outcome	Collect patient report outcome data on anxiety before and after using virtual reality mindfulness meditation.	Up to 1 day (before and after VR use)
Pain Outcome	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)

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Anticipated): July 10, 2023
• Study Completion (Anticipated): July 10, 2023

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Acute Pain
• Other Study ID Numbers: 45300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No