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临床试验/CTRI/2025/09/094386
CTRI/2025/09/094386尚未招募不适用

Assessment of the effectiveness of pursed lip breathing along with music therapy on reduction of blood pressure and heart rate among patients with hypertensive urgency. – A Randomized controlled trial.

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2025年9月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
144
试验地点
1
主要终点
To assess the effectiveness of pursed-lip breathing along with music therapy on blood pressure and heart rate among Hypertensive urgency Patients.

研究概览

简要总结

The study will be conducted in the Emergency Department of JIPMER after receiving approval from the Institutional Ethics Committee. Participants will be selected based on predefined inclusion and exclusion criteria. Eligible individuals will be randomly allocated into two groups: a study group and a control group. Informed consent will be obtained from all participants before the study begins. The intervention will start 10 to 15 minutes after the administration of antihypertensive medications. Baseline assessments of blood pressure and heart rate will be taken using a digital sphygmomanometer and pulse oximeter.

Intervention group

Participants in the study group will be seated in a designated area called the Hypertensive Corner and placed in a semi-Fowler position. They will undergo a 3-hour intervention that includes pursed-lip breathing with number counting for the first 15 minutes of every hour, demonstrated by a student nurse researcher using a card set. For the remaining 45 minutes of each hour, participants will receive music therapy. Before starting, they will preview four instrumental Raga Ahir Bhairav tracks for 30 seconds and select their preferred piece. The selected music will be played using noise-cancelling headphones. This cycle will be repeated for the full 3 hour period or until discharge or withdrawal from the study. A student nurse researcher will remain with each participant throughout the session to ensure proper technique and adherence. Participants will also receive standard care as per hospital protocol.

Control group

The control group will receive only standard care during the study. After the final assessment, the control group will be given a demonstration of pursed-lip breathing with number counting.

Details of Assessment

Blood Pressure and Heart Rate will be measured every hour. A total of 4 times means baseline, first hour, second hour, third hour BP assessment will be done. For statistical assessment, baseline data and, in the end, 3 hour data will be considered. In between, assessment will be done to check the patients hemodynamic state.

Periodicity

Total****intervention time 3 hour it include 15 minpursed-lip breathing with number counting and remaining 45 min music therapy

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adult age more than 18 yr old with Hypertensive urgency after arriving at JIPMER emergency dept.

排除标准

  • Patient with severe medical condition like- cardiac arrythmia, Acute coronary syndrome ,Acute Heart failure ,Acute stroke, Acute Respiratory Failure , Alteration of consciousness Patient with hearing disabilities Pregnant women.
  • Patient with severe psychiatric disorder.
  • Participants enrolled in other studies.

结局指标

主要结局

To assess the effectiveness of pursed-lip breathing along with music therapy on blood pressure and heart rate among Hypertensive urgency Patients.

时间窗: after 3 hour frame baseline assessment

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr M J Kumari

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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