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

NCT04534101 | Suspended

• 1 other identifier: 45300
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain; Chronic Pain

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

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

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

Interventions

Virtual Reality Mindfulness BEHAVIORAL

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.

Inpatient Subjects; Outpatient Subjects

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants must:
• be between ages of 5-80 years of age
• have comprehension of instructions in the English language
• English speaking
• Must be able to comprehend ICF
• Have a medical appointment or procedure at Stanford/LPCH (inpatient or outpatient) that may cause pain or anxiety.

You may not qualify if:

• Significant cognitive impairment/developmental delays
• Seizure Disorder
• history of motion sickness with virtual reality
• severe visual impairment

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda Nguyen, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 1, 2020
• Study Start: July 10, 2018
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

US (1)