Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04534101
Status:
SUSPENDED
Last Update Posted:
2022-08-22
First Post:
2020-08-26
Brief Title:
Medical Mindfulness Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Patients With Acute and Chronic Pain
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Medical Mindfulness Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Patients With Acute and Chronic Pain
Status:
SUSPENDED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Temporarily paused due to COVID-19 and expected to resume Resumption timeline unclear due ongoing pandemic This is not a suspension of IRB approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR Mindfulness
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 ie 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 ie 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 Patients 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 Patients 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 BoxPatients will not be entering their PHI we will know who has headsets as they will be numbered
Outpatient Patients 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 BoxPatients will not be entering their PHI we will know who has headsets as they will be numbered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None