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White Coat HypertensionNCT06960057

Virtual Reality as a Tool to Lower Blood Pressure and Anxiety in Clinic Settings

A study testing Virtual Reality Exposure in people with White Coat Hypertension and Hypertension, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Virtual Reality Exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteUnited States
Study dates
2 Jun 2025to 15 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older.
  • Undergoing ambulatory blood pressure monitoring (ABPM) at Mayo Clinic Florida for any clinical indication.
  • Able and willing to provide informed consent.

Who cannot join

  • History of epilepsy or seizure disorders.
  • Significant cognitive impairment (e.g., dementia, Alzheimer's disease).
  • Significant visual impairment that prevents visualization of the VR environment.
  • History of vestibular disorders (e.g., Meniere's disease, chronic vertigo).
  • Unstable cardiovascular conditions (e.g., myocardial infarction within the past year).
  • Chronic hypoxemic respiratory failure requiring supplemental oxygen.
  • Cervical spine instability or injuries that could impair safe VR use.
  • Current pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic Florida

    Jacksonville, Florida, 32081

Other trials in United States

About this study

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

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:

Read more
  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.

Read the 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.

Being tested
Virtual Reality Exposure
Keywords
White Coat Hypertension, White Coat Effect, Hypertension, Ambulatory Blood Pressure Monitoring, Office Blood Pressure, Virtual Reality, VR Headset, Anxiety Reduction, Stress Reduction, Calming Intervention, Virtual Reality in Medicine
Medical subject headings
White Coat Hypertension, Hypertension, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality ExposureBehavioural

    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.

Study groups in NCT06960057
Study groupRoleWhat they receive
Virtual Reality InterventionExperimentalParticipants 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.
Receives: Behavioral: Virtual Reality Exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline (pre-VR exposure) and immediately post-intervention (post-VR exposure) during the study visit.

Secondary outcomes (5)
  1. 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.

    Measured: Baseline (average daytime BP from ABPM prior to study visit) and next day follow-up study visit during ABPM device return.

  2. 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.

    Measured: Baseline (pre-VR exposure) and immediately post-intervention (post-VR exposure) during the study visit.

  3. 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).

    Measured: Baseline (pre-VR exposure) and immediately post-intervention (post-VR exposure) during the study visit.

  4. 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.

    Measured: Immediately post-intervention (post-VR exposure) during the study visit.

  5. 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.

    Measured: Immediately post-intervention (post-VR exposure) during the study visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study start2 Jun 2025
  3. Primary completion15 Aug 2025
  4. Study completion15 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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).
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06960057
Sponsor's protocol ID
25-000347
Status last verified
May 2025
First submitted
21 Apr 2025
Last updated
5 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29133356
  • 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.

    PubMed 16738273
  • 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.

    PubMed 28325167
  • 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.

    PubMed 33631382
  • Baker LW, Karthik R, Munlapudi VR, Balog J, Mao MA, Trautman CL, Ma Y, Fang ZJ, Porter IE. Virtual Reality Reduces Office Blood Pressure and Anxiety in Patients Undergoing Ambulatory Blood Pressure Monitoring: Enhanced Response among Those With a Pronounced White Coat Response. J Clin Hypertens (Greenwich). 2026 Sep;28(9):e70360. doi: 10.1111/jch.70360.

    PubMed 42723367

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Exposure in people with White Coat Hypertension and Hypertension, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Office Blood Pressure (OBP) Before and After VR Exposure (time frame: Baseline (pre-VR exposure) and immediately post-intervention (post-VR exposure) during the study visit.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06960057, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.

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