Mayo Clinic Florida
Jacksonville, Florida, 32081, United States
NCT Number: NCT06960057
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Jacksonville, Florida, 32081, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline (pre-VR exposure) and immediately post-intervention (post-VR exposure) during the study visit.
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).
Time frame: Baseline (average daytime BP from ABPM prior to study visit) and next day follow-up study visit during ABPM device return.
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.
Time frame: Baseline (pre-VR exposure) and immediately post-intervention (post-VR exposure) during the study visit.
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.
Time frame: Baseline (pre-VR exposure) and immediately post-intervention (post-VR exposure) during the study visit.
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).
Time frame: Immediately post-intervention (post-VR exposure) during the study visit.
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.
Time frame: Immediately post-intervention (post-VR exposure) during the study visit.
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.
Mayo Clinic
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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