| CTRI Number |
CTRI/2025/03/081562 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pursed lip breathing combined with number counting effects on blood pressure and heart rate in hypertensive urgency patients. |
|
Scientific Title of Study
|
The effect Of Pursed-lip breathing combined with number counting on blood pressure and heart rate in hypertensive urgency patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotheray,Datta Meghe College of Physiotherapy,Shri Datta Meghe polytechnic Campus
Wanadongri,Hingna Road,
Nagpur
441110
MAHARASHTRA
INDIA
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9579946849 |
| Fax |
|
| Email |
nikkiforeverz408@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms.Shweta Ashok Panchbudhe |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotheray,Datta Meghe College of Physiotherapy,Shri Datta Meghe polytechnic Campus
Wanadongri,Hingna Road,
Nagpur
441110
MAHARASHTRA
INDIA
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9049169589 |
| Fax |
|
| Email |
Shweta12panchbudhe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Gupta |
| Designation |
Post Graduate student |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotheray,Datta Meghe College of Physiotherapy,Shri Datta Meghe polytechnic Campus
Wanadongri,Hingna Road,
Nagpur
441110
MAHARASHTRA
INDIA
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9579946849 |
| Fax |
|
| Email |
nikkiforeverz408@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalinitai Meghe Hospital and Research Institute, Wanadongri, Hingna Nagpur-441110,Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Nikita Gupta |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy,Datta Meghe College of Physiotherapy,Shri Datta Meghe Polytchnic Campus
Wanadongri
Nagpur
Maharashtra
India
|
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrNikita Gupta |
Shalinitai Meghe Hospital and Research Institute. |
Shalinitai Meghe Hospital and Research Institute.
Emergency Room No-3,Medicine department,Ground floor,
Wanadongri ,
Nagpur,441110
Maharashtra,
India.
Nagpur
MAHARASHTRA |
9579946849
nikkiforeverz408@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved,Physiotherapy,Nursing(APN)CollegesInstitutional Ethical committee |
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 |
| Comparator Agent |
Usual care and antihypertensive drugs |
The patients who were allocated to the control group received usual care with rest in a supine position quiet area Hypertension Corner in the ER. Patients were advised to limit their activity. Vital sign monitoring was carried out with the same frequency for both the intervention and control groups. Pharmacologic treatment was prescribed according to the judgment |
| Intervention |
Pursed lip breathing with number counting with antihypertive drugs |
Pursedlip breathing and number counting one and two during inhalation and number counting one two three and four during exhalation For only the first 15 minutes of each hour to prevent exhaustion of total 3hrs |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with hypertensive urgency
2.Prescribed antihypertensive medications in emergency room.
3.Age 45years-80yearsr |
|
| ExclusionCriteria |
| Details |
1.Patients with cardiac arrhythmias, acute HF, acute coronary syndrome, acute stroke, acute respiratory failure, alteration of consciousness, or pregnancy .
2.Patients receiving IV antihypertensive medication or needing oxygen or ventilation support s
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate hypertensive urgency patients.
To evaluate effect of pursed lip breathing with number counting on blood pressure.
To evaluate effect of pursed lip breathing with number counting on heart rate.
|
pre-intervention at 1st hour
post-intervention at 3rd hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare effect of pursed lip breathing with number counting on blood pressure and heart rate. |
post-intervention at 3rd hour |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Hypertensive urgency is marked by a significant elevation in blood pressure (BP) exceeding 180/110 mm Hg without target organ damage, posing a risk of future cardiovascular events like atrial fibrillation, heart failure, myocardial infarction, or stroke. While under ER observation, alongside standard care, non-pharmacological interventions like breathing exercises may aid in BP reduction. Slow, deep breathing enhances baroreflex sensitivity, heart rate variability, and blood flow while reducing vascular resistance, with evidence suggesting its potential benefits in stress relief and BP control, although data in emergency settings remain limited. This randomized clinical trial aimed to evaluate the effect of pursed-lip breathing combined with number counting on blood pressure and heart rate in hypertensive urgency patients Procedure- participants will be selected and screened based on inclusion and exclusion criteria. Details about intervention will be explained to the participants and an informed consent form will be obtained. Group A and Group B, receiving conventional antihypertensive drug and pre assessment of baseline blood pressure and heart rate done. Group A - patient in a semi-supine position with the bed adjusted to 45-60 degrees; Pursed-lip breathing and number counting one and two during inhalation; and number counting one, two, three, and four†during exhalation . For only the first 15 minutes of each hour to prevent exhaustion of total 3hrs. Group B : The control group received usual care, that is, bed rest in a supine position in a quiet area Patients were advised to limit their activity. Vital sign monitoring was carried out with the same frequency for both the intervention and control groups. Statistical test will be used to see the effect of pursed-lip breathing combined with number counting in enhancing outcomes in hypertensive urgency patients |