Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| E2-24-7802 | Other Identifier | Ankara Bilkent City Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Pharmacological Treatment | Active Comparator | Participants in this arm will receive standard oral antihypertensive treatment consisting of 25 mg captopril. Additional doses (25 mg at 30 minutes and 25 mg at 60 minutes, total 75 mg) will be administered if systolic blood pressure remains ≥180 mmHg or diastolic blood pressure remains ≥110 mmHg during follow-up. Rescue therapy with IV nitrate (0.1 mg/kg/min) will be used if blood pressure remains uncontrolled after 90 minutes, following routine emergency department protocol. No VR or music therapy is administered in this arm. |
|
| Standard Treatment + VR and Classical Music Therapy | Experimental | Participants in this arm will receive standard oral antihypertensive treatment consisting of 25 mg captopril. Additional doses (25 mg at 30 minutes and 25 mg at 60 minutes, total 75 mg) will be administered if systolic blood pressure remains ≥180 mmHg or diastolic blood pressure remains ≥110 mmHg during follow-up. In addition to standard treatment, participants will receive virtual reality exposure combined with classical music therapy. Patients will view a calming VR environment while listening to a selected piece of classical music. VR and music therapy are administered concurrently in a quiet and dimly lit room. Rescue therapy with IV nitrate (0.1 mg/kg/min) will be used if blood pressure remains uncontrolled after 90 minutes, following the same emergency department protocol as the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Captopril 25Mg Tab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Arterial Pressure (MAP) at 30 Minutes | 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. | Baseline (after 10 minutes of rest) and 30 minutes after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in State Anxiety Level (State Anxiety Inventory - Form I) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara | Çankaya | 06170 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37644380 | Result | Vorwerg-Gall S, Stamm O, Haink M. Virtual reality exergame in older patients with hypertension: a preliminary study to determine load intensity and blood pressure. BMC Geriatr. 2023 Aug 30;23(1):527. doi: 10.1186/s12877-023-04245-x. | |
| 38132649 | Result | Jiravska Godula B, Jiravsky O, Matheislova G, Kuriskova V, Valkova A, Puskasova K, Dokoupil M, Dvorakova V, Prifti A, Foral D, Jiravsky F, Hecko J, Hudec M, Neuwirth R, Miklik R. Virtual Reality for Patient Education about Hypertension: A Randomized Pilot Study. J Cardiovasc Dev Dis. 2023 Nov 29;10(12):481. doi: 10.3390/jcdd10120481. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000096003 | Hypertensive Crisis |
| D000075222 | Essential Hypertension |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| D002216 | Captopril |
| ID | Term |
|---|---|
| D011392 | Proline |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
|
| Virtual Reality Exposure | Device | 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 |
|
| Classic Music Therapy | Behavioral | 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. |
|
| Baseline and 120 minutes |
| Incidence of Adverse Events | 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. | Up to 120 minutes |
| 27294333 | Result | Patel KK, Young L, Howell EH, Hu B, Rutecki G, Thomas G, Rothberg MB. Characteristics and Outcomes of Patients Presenting With Hypertensive Urgency in the Office Setting. JAMA Intern Med. 2016 Jul 1;176(7):981-8. doi: 10.1001/jamainternmed.2016.1509. |
| 36418425 | Result | Kulkarni S, Glover M, Kapil V, Abrams SML, Partridge S, McCormack T, Sever P, Delles C, Wilkinson IB. Management of hypertensive crisis: British and Irish Hypertension Society Position document. J Hum Hypertens. 2023 Oct;37(10):863-879. doi: 10.1038/s41371-022-00776-9. Epub 2022 Nov 22. |
| 34825613 | Result | Qin Z, Zhou C, Zhu Y, Wang Y, Cao H, Li W, Huang Z. Virtual Reality for Hypertension in Tooth Extraction: A Randomized Trial. J Dent Res. 2022 Apr;101(4):400-406. doi: 10.1177/00220345211049393. Epub 2021 Nov 26. |
| 32371787 | Result | Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension global hypertension practice guidelines. J Hypertens. 2020 Jun;38(6):982-1004. doi: 10.1097/HJH.0000000000002453. No abstract available. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |