| CTRI Number |
CTRI/2025/09/094386 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [pursed lip breathing and music therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see if breathing exercises and music help reduce high blood pressure and fast heart rate in people with sudden rise in blood pressure. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M J Kumari |
| Designation |
Professor , Principal (Ag), JIPMER |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room no- 100, ground floor College of Nursing ,Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M J Kumari |
| Designation |
Professor , Principal (Ag), JIPMER |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room No-100,ground floor College of Nursing ,Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adriza Acharjee |
| Designation |
M.Sc Nursing Student |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
room no-102,M.Sc Nursing second year classroom, College of Nursing ,Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9382211812 |
| Fax |
|
| Email |
adrizaacharjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Intramural fund committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M J Kumari |
Emergency Medicine & Trauma Department JIPMER |
Room No-5A, Ground floor, Emergency Medicine & Trauma Department JIPMER, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY |
9894595420
kumari_mj@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - INTERVENTIONAL STUDIES JIPMER, PUDUCHERRY. CDSCO Reg. No: ECR/342/Inst/PY/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I160||Hypertensive urgency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
pursed lip breathing along with music therapy |
patients will be placed in Fowler’s position (45–60°) and guided by a student nurse researcher to perform pursed-lip breathing with number counting for the first 15 minutes of each hour. For the remaining 45 minutes, patients will undergo music therapy using noise-canceling headphones, selecting one of four Raga Ahir Bhairav instrumental tracks. The total study duration per patient is 3 hours, with BP monitored hourly (baseline and 3rd-hour readings used for analysis). Patients will rest in a quiet ER area (“Hypertension Corner”) and receive standard care. The nurse ensures adherence to both breathing and music therapy protocols. |
| Comparator Agent |
standard care as per hospital protocol |
The control group will receive standard care as per hospital protocol without additional intervention. After the last assessment control group will have a demonstration of pursed-lip breathing with number counting by the nurse researcher by using a card set. total duration 3 hour and hourly check the BP. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult age more than 18 yr old with Hypertensive urgency after arriving at JIPMER emergency dept. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of pursed-lip breathing along with music therapy on blood pressure and heart rate among Hypertensive urgency Patients. |
after 3 hour frame baseline assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/09/2025 |
| Date of Study Completion (India) |
06/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 min pursed-lip breathing with number counting and remaining 45 min music therapy
|