Clinical trial NCT04534101: Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Patients With Acute and Chronic Pain
Official title: Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Patients With Acute and Chronic Pain
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Acute Pain
Chronic Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: VR Mindfulness Acceptability
timeFrame: Up to 1 day (before and after VR use)
measure: Anxiety Outcome
timeFrame: Up to 1 day (before and after VR use)
measure: Pain Outcome
timeFrame: Up to 1 day (before and after VR use)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Linda Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: