Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-28 @ 11:55 AM
Study NCT ID:
NCT06960057
Status:
COMPLETED
Last Update Posted:
2025-11-05
First Post:
2025-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality as a Tool to Lower Blood Pressure and Anxiety in Clinic Settings
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Exploring Virtual Reality as a Clinical Tool for Blood Pressure Reduction and Assessment of White Coat Hypertension/Effect: A Pre- and Post-Intervention Study With ABPM Validation
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to evaluate whether a calming virtual reality (VR) experience can reduce office blood pressure (OBP) and anxiety in adults undergoing ambulatory blood pressure monitoring (ABPM) at Mayo Clinic in Florida.
The main questions it aims to answer are:
1. Does a 5-minute calming VR session reduce office blood pressure in patients with suspected white coat hypertension or white coat effect?
2. Does VR exposure reduce self-reported anxiety levels in the clinical setting?
3. Does VR reduce the difference between home (ABPM) and clinic blood pressure readings?
Participants will:
1. Complete two short electronic surveys (before and after VR exposure) on a clinic-provided device.
2. Undergo a 5-minute virtual reality (VR) relaxation session.
3. Have their blood pressure measured before and after the VR session.
Participation will occur during the participant's scheduled ABPM device return visit and will add approximately 30 minutes to the visit.
This is a single-arm, pre-post interventional study where each participant serves as their own control.
The main questions it aims to answer are:
1. Does a 5-minute calming VR session reduce office blood pressure in patients with suspected white coat hypertension or white coat effect?
2. Does VR exposure reduce self-reported anxiety levels in the clinical setting?
3. Does VR reduce the difference between home (ABPM) and clinic blood pressure readings?
Participants will:
1. Complete two short electronic surveys (before and after VR exposure) on a clinic-provided device.
2. Undergo a 5-minute virtual reality (VR) relaxation session.
3. Have their blood pressure measured before and after the VR session.
Participation will occur during the participant's scheduled ABPM device return visit and will add approximately 30 minutes to the visit.
This is a single-arm, pre-post interventional study where each participant serves as their own control.
Detailed Description:
This is a prospective, single-arm, pre-post interventional study designed to evaluate the effect of a calming virtual reality (VR) experience on office blood pressure (OBP), home-clinic BP differences, and self-reported anxiety levels in adults undergoing ambulatory blood pressure monitoring (ABPM) at Mayo Clinic in Florida.
White coat hypertension (WCH) and white coat effect (WCE) are conditions where patients exhibit elevated OBP readings in clinical settings that are not representative of their typical blood pressure levels in non-clinical environments. These conditions can lead to misdiagnosis and unnecessary treatment. ABPM is considered the gold standard for differentiating true hypertension from WCH/WCE. Emerging evidence suggests that virtual reality can reduce anxiety and physiological stress responses, making it a promising tool for improving the accuracy of clinic-based blood pressure assessments.
The study will enroll up to 250 participants, with a target accrual of 200 completed cases. Participants are identified through electronic medical records as individuals scheduled for ABPM. Those who meet eligibility criteria and provide informed consent will participate during a single clinic visit coinciding with the return of their ABPM device.
During the study visit, participants will:
1. Complete a short electronic survey (via REDCap on a clinic-provided device) capturing information about their history of hypertension or white coat hypertension/effect, mental health conditions, use of medications for anxiety or mood disorders, anxiety related to doctor visits, recent caffeine intake, and prior VR experience.
2. Complete two standardized anxiety assessments (the Visual Analog Scale \[VAS\] for anxiety and the State-Trait Anxiety Inventory-6 \[STAI-6\]) prior to VR exposure.
3. Undergo three resting office blood pressure (OBP) measurements using an automated blood pressure cuff, with results averaged.
4. Participate in a 5-minute immersive VR session featuring a calming, nature-based environment.
5. Undergo three additional resting OBP measurements after VR exposure, with results averaged.
6. Complete repeat VAS and STAI-6 anxiety assessments following the VR session.
7. Complete a brief post-VR survey evaluating comfort, relaxation, side effects, and overall experience.
8. Permit research staff to review their Mayo Clinic electronic medical record for demographic information, relevant medical history, current medications, office blood pressure readings at the ABPM fitting, and ABPM study results.
The study's primary objective is to assess the change in OBP before and after VR exposure. Secondary objectives include evaluating the change in the home-clinic BP difference and measuring changes in anxiety scores. Exploratory analyses will examine predictors of VR responsiveness, including age, sex, baseline anxiety, and history of mental health conditions
This study is minimal risk. The VR headset used is commercially available and not being evaluated as an FDA-regulated device. Adverse effects from VR are expected to be rare and may include mild dizziness or nausea.
This research seeks to generate evidence on whether VR can be used as a simple, non-invasive tool to reduce OBP and anxiety in patients at risk for WCH or WCE and improve the reliability of in-clinic BP measurements. The findings may inform future strategies for integrating VR into routine hypertension care.
White coat hypertension (WCH) and white coat effect (WCE) are conditions where patients exhibit elevated OBP readings in clinical settings that are not representative of their typical blood pressure levels in non-clinical environments. These conditions can lead to misdiagnosis and unnecessary treatment. ABPM is considered the gold standard for differentiating true hypertension from WCH/WCE. Emerging evidence suggests that virtual reality can reduce anxiety and physiological stress responses, making it a promising tool for improving the accuracy of clinic-based blood pressure assessments.
The study will enroll up to 250 participants, with a target accrual of 200 completed cases. Participants are identified through electronic medical records as individuals scheduled for ABPM. Those who meet eligibility criteria and provide informed consent will participate during a single clinic visit coinciding with the return of their ABPM device.
During the study visit, participants will:
1. Complete a short electronic survey (via REDCap on a clinic-provided device) capturing information about their history of hypertension or white coat hypertension/effect, mental health conditions, use of medications for anxiety or mood disorders, anxiety related to doctor visits, recent caffeine intake, and prior VR experience.
2. Complete two standardized anxiety assessments (the Visual Analog Scale \[VAS\] for anxiety and the State-Trait Anxiety Inventory-6 \[STAI-6\]) prior to VR exposure.
3. Undergo three resting office blood pressure (OBP) measurements using an automated blood pressure cuff, with results averaged.
4. Participate in a 5-minute immersive VR session featuring a calming, nature-based environment.
5. Undergo three additional resting OBP measurements after VR exposure, with results averaged.
6. Complete repeat VAS and STAI-6 anxiety assessments following the VR session.
7. Complete a brief post-VR survey evaluating comfort, relaxation, side effects, and overall experience.
8. Permit research staff to review their Mayo Clinic electronic medical record for demographic information, relevant medical history, current medications, office blood pressure readings at the ABPM fitting, and ABPM study results.
The study's primary objective is to assess the change in OBP before and after VR exposure. Secondary objectives include evaluating the change in the home-clinic BP difference and measuring changes in anxiety scores. Exploratory analyses will examine predictors of VR responsiveness, including age, sex, baseline anxiety, and history of mental health conditions
This study is minimal risk. The VR headset used is commercially available and not being evaluated as an FDA-regulated device. Adverse effects from VR are expected to be rare and may include mild dizziness or nausea.
This research seeks to generate evidence on whether VR can be used as a simple, non-invasive tool to reduce OBP and anxiety in patients at risk for WCH or WCE and improve the reliability of in-clinic BP measurements. The findings may inform future strategies for integrating VR into routine hypertension care.
Study Oversight
Has Oversight DMC:
False
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?: