Hypertensive Urgency, Primary Hypertension
Conditions
Keywords
Hypertensive Urgency, Primary Hypertension, Virtual Reality Therapy, Classical Music Therapy, Stress Reduction, Blood Pressure Control, Emergency Department
Brief summary
This study aims to evaluate whether virtual reality (VR) and classical music therapy, when added to standard antihypertensive treatment, can improve blood pressure control and reduce anxiety in patients presenting to the emergency department with hypertensive urgency. Patients with primary hypertension and no signs of end-organ damage will be randomly assigned to receive either standard treatment alone or standard treatment combined with VR and classical music. Blood pressure will be monitored at multiple time points over a 120-minute period, and anxiety will be assessed using the State Anxiety Inventory (STAI-I). The study seeks to determine if these non-pharmacological interventions can enhance the effectiveness of routine management of hypertensive urgency.
Detailed description
Hypertensive urgency is characterized by severely elevated blood pressure without evidence of acute target-organ damage. Standard management typically involves the gradual reduction of blood pressure using oral antihypertensive agents such as captopril. Emotional stress and anxiety can contribute to elevated sympathetic activity, potentially worsening blood pressure control. Virtual reality (VR) environments and classical music therapy have been shown in prior studies to reduce stress, improve patient comfort, and modulate physiological responses. In this randomized controlled study, patients with primary hypertension who present to the emergency department with hypertensive urgency will be assigned to one of two groups: standard pharmacological treatment alone or standard treatment combined with VR exposure and classical music therapy. The intervention will be delivered in a quiet and dimly lit room, and blood pressure will be measured at predefined intervals over 120 minutes. Anxiety levels will be assessed at baseline and at the end of the monitoring period using the State Anxiety Inventory (STAI-I). This study aims to determine whether VR and classical music can enhance routine management by improving early percentage change in mean arterial pressure and decreasing anxiety levels during acute hypertensive episodes. Findings may support the incorporation of non-pharmacological strategies into the emergency management of hypertensive urgency.
Interventions
This drug is administered to participants in both study arms. Standard oral antihypertensive treatment with 25 mg captopril is given at baseline, with additional doses administered during follow-up as needed according to the study protocol. Rescue therapy with IV nitrate (0.1 mg/kg/min) may be used if blood pressure remains uncontrolled after 90 minutes.
DEVICEVirtual Reality Exposure
This intervention is administered only to participants in the 'Standard Treatment + VR and Classical Music Therapy' arm. Participants view a calming virtual environment of their choice using a non-proprietary VR headset.The session is delivered concurrently with standard antihypertensive treatment in a quiet, dimly lit room
BEHAVIORALClassic Music Therapy
This intervention is administered only to participants in the 'Standard Treatment + VR and Classical Music Therapy' arm. Participants listen to one of several selected classical music pieces at a comfortable volume (40-60 dB) during the VR exposure. Music therapy is applied simultaneously with standard antihypertensive treatment to support relaxation.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study uses a two-arm parallel assignment model in which participants are randomized in a 1:1 ratio to receive either standard pharmacological treatment alone or standard treatment combined with virtual reality and classical music therapy. All interventions are delivered concurrently with routine management in a controlled emergency department environment, and participants are followed for 120 minutes with repeated blood pressure and anxiety assessments
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Clinical diagnosis of primary hypertension * Presentation to the emergency department with hypertensive urgency * Absence of any signs of acute end-organ damage * Ability to understand the study and provide informed consent * Able to cooperate with serial blood pressure measurements
Exclusion criteria
* Age younger than 18 years * Diagnosis of secondary hypertension * Any medication intolerance or known hypersensitivity to captopril or nitrate therapy * Current severe psychiatric disorder or cognitive impairment interfering with participation * Contraindications to using virtual reality (history of severe vertigo, epilepsy, motion sickness, etc.) * Hemodynamic instability requiring immediate high-intensity medical intervention * Pregnancy or breastfeeding * Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Arterial Pressure (MAP) at 30 Minutes | Baseline (after 10 minutes of rest) and 30 minutes after treatment initiation | Mean arterial pressure will be measured at baseline (after 10 minutes of rest) and again at 30 minutes after the initial treatment. The primary endpoint is the percentage change in MAP at 30 minutes compared with baseline. Positive values indicate a reduction in MAP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in State Anxiety Level (State Anxiety Inventory - Form I) | Baseline and 120 minutes | State anxiety will be measured using the State Anxiety Inventory - Form I (STAI-I), a validated 20-item scale assessing situational anxiety. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety. STAI-I will be administered at baseline and at 120 minutes to evaluate changes during the observation period. |
| Incidence of Adverse Events | Up to 120 minutes | Frequency and type of adverse events related to antihypertensive medication or VR/music therapy (e.g., dizziness, nausea, hypotension) will be documented during the entire observation period. |
Countries
Turkey (Türkiye)
Outcome results
None listed