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

Chronic Pain Clinical Trial

— VR Mindfulness  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04534101
• Other study ID #: 45300
• Status: Suspended
• Start date: July 10, 2018
• Est. completion date: July 10, 2023

Study information

• Verified date: August 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 500
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Gender: All
• Age group: 5 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)