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

NCT06960057 | Completed

• 1 other identifier: 25-000347
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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. 1.Does a 5-minute calming VR session reduce office blood pressure in patients with suspected white coat hypertension or white coat effect?
2. 2.Does VR exposure reduce self-reported anxiety levels in the clinical setting?
3. 3.Does VR reduce the difference between home (ABPM) and clinic blood pressure readings?
4. 4.Complete two short electronic surveys (before and after VR exposure) on a clinic-provided device.
5. 5.Undergo a 5-minute virtual reality (VR) relaxation session.
6. 6.Have their blood pressure measured before and after the VR session.

Conditions

White Coat Hypertension; Hypertension; Blood Pressure; Anxiety; Virtual Reality Exposure Therapy; Ambulatory Blood Pressure Monitoring; Blood Pressure Disorders

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

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (5)

• Change in Home-Clinic Blood Pressure Difference After VR Exposure

  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

  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

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

• Patient-Reported Acceptability and Satisfaction with the VR Experience

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

• Incidence of Adverse Effects Related to VR Exposure

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

Study Arms (1)

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.

Behavioral: Virtual Reality Exposure

Interventions

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.

Virtual Reality Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32081, United States

Location

Related Publications (4)

• 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.

  PMID: 29133356 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.

  PMID: 16738273 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.

  PMID: 28325167 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.

  PMID: 33631382 BACKGROUND

Related Links

• Can A Five-Minute Virtual Reality Headset Intervention Reduce Blood Pressure In Patients With White-Coat Hypertension?

MeSH Terms

Conditions

White Coat Hypertension; Hypertension; Anxiety Disorders

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lyle W Baker, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Medical Director of the Hypertension Center, Mayo Clinic Florida

Model Details: 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).

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 7, 2025
• Study Start: June 2, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: November 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)