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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:
Participants will:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Intervention | Experimental | Participants undergoing ambulatory blood pressure monitoring (ABPM) will receive a 5-minute calming virtual reality (VR) session. Blood pressure and anxiety levels will be measured before and after VR exposure to evaluate its effect on office blood pressure and emotional response in a clinical setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Exposure | Behavioral | Participants will be exposed to a standardized 5-minute virtual reality (VR) session using a commercially available VR headset. The session features a calming, immersive environment intended to reduce anxiety and lower office blood pressure (OBP) during a clinical visit. The VR experience is delivered after the return of an ambulatory blood pressure monitoring (ABPM) device and before the final BP measurements are obtained. Blood pressure and anxiety scores are assessed immediately before and after VR exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Office Blood Pressure (OBP) Before and After VR Exposure | The primary outcome is the within-subject change in office blood pressure (systolic, diastolic, and mean arterial pressure) measured immediately before and after a standardized 5-minute calming VR session among patients with suspected white coat hypertension (WCH) or white coat effect (WCE). Blood pressure is measured in triplicate using an automated device, with the average of the three readings recorded both pre- and post-VR exposure. Effectiveness will be assessed by comparing pre- and post-VR OBP measurements. Diagnosis of WCH or WCE will be confirmed through ambulatory blood pressure monitoring (ABPM). | Baseline (pre-VR exposure) and immediately post-intervention (post-VR exposure) during the study visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Home-Clinic Blood Pressure Difference After VR Exposure | This outcome compares the home-clinic blood pressure difference (defined as the difference between average daytime ambulatory blood pressure monitoring [ABPM] and in-clinic office BP) before and after VR exposure. The goal is to assess whether VR reduces the magnitude of the difference between ABPM readings and in-clinic measurements. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyle W Baker, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32081 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29133356 | Background | Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available. | |
| 16738273 |
| Label | URL |
|---|---|
| Can A Five-Minute Virtual Reality Headset Intervention Reduce Blood Pressure In Patients With White-Coat Hypertension? | View source |
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This is a single-arm, pre-post interventional study in which all participants receive the same virtual reality (VR) intervention. Each participant undergoes office blood pressure (OBP) measurement and anxiety assessment both before and after a standardized 5-minute VR session. The study evaluates within-subject changes to determine whether VR exposure affects OBP and anxiety levels in adults that will be undergoing ambulatory blood pressure monitoring (ABPM).
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|
| Baseline (average daytime BP from ABPM prior to study visit) and next day follow-up study visit during ABPM device return. |
| Change in Visual Analog Scale (VAS) for Anxiety Before and After VR Exposure | The Visual Analog Scale (VAS) for anxiety is a 0-10 scale where participants rate their current anxiety level. A score of 0 indicates no anxiety and a score of 10 indicates the highest possible anxiety. Higher scores reflect worse anxiety symptoms. | Baseline (pre-VR exposure) and immediately post-intervention (post-VR exposure) during the study visit. |
| Change in State-Trait Anxiety Inventory-6 (STAI-6) Scores Before and After VR Exposure | The State-Trait Anxiety Inventory-6 (STAI-6) is a validated six-item questionnaire assessing current (state) anxiety. Each item is scored on a 1-4 Likert scale, with a total possible score ranging from 6 to 24. Higher scores indicate greater anxiety. Units on a scale (6-24). | Baseline (pre-VR exposure) and immediately post-intervention (post-VR exposure) during the study visit. |
| Patient-Reported Acceptability and Satisfaction with the VR Experience | Participants will complete a brief post-intervention survey evaluating their experience with the VR session, including comfort, perceived relaxation, and willingness to use VR in future medical visits. | Immediately post-intervention (post-VR exposure) during the study visit. |
| Incidence of Adverse Effects Related to VR Exposure | Any participant-reported side effects during or immediately following the VR session (e.g., dizziness, nausea, eye strain, anxiety) will be recorded. Staff will monitor participants throughout the session and document any discomfort or early discontinuation of VR. | Immediately post-intervention (post-VR exposure) during the study visit. |
| Background |
| Pickering TG, Shimbo D, Haas D. Ambulatory blood-pressure monitoring. N Engl J Med. 2006 Jun 1;354(22):2368-74. doi: 10.1056/NEJMra060433. No abstract available. |
| 28325167 | Background | Freeman D, Reeve S, Robinson A, Ehlers A, Clark D, Spanlang B, Slater M. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017 Oct;47(14):2393-2400. doi: 10.1017/S003329171700040X. Epub 2017 Mar 22. |
| 33631382 | Background | Ma H, Bian Y, Wang Y, Zhou C, Geng W, Zhang F, Liu J, Yang C. Exploring the effect of virtual reality relaxation environment on white coat hypertension in blood pressure measurement. J Biomed Inform. 2021 Apr;116:103721. doi: 10.1016/j.jbi.2021.103721. Epub 2021 Feb 22. |
| ID | Term |
|---|---|
| D059466 | White Coat Hypertension |
| D006973 | Hypertension |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D063367 | Virtual Reality Exposure Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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