| CTRI Number |
CTRI/2026/03/105477 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| 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
|
Effect of Pursed-lip breathing and breath stacking on oxygenation saturation,Breathing Rate, and Heart Rate in Patients after Hysterectomy. |
|
Scientific Title of Study
|
Effect of pursed lip breathing and breath stacking on physiological Parameters (Sp02, respiratory rate and heart rate) in post-hysterectomy patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayaraman G |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy Department |
| Address |
Physiotherapy Department Punjabi University Patiala Punjab 147002 India
Patiala
PUNJAB
147002
India |
| Phone |
9914889469 |
| Fax |
|
| Email |
jayaraman_mpt@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayaraman G |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy Department |
| Address |
Physiotherapy Department Punjabi University Patiala Punjab 147002 India
PUNJAB
147002
India |
| Phone |
9914889469 |
| Fax |
|
| Email |
jayaraman_mpt@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mehak |
| Designation |
Postgraduate Student |
| Affiliation |
Physiotherapy Department |
| Address |
Physiotherapy Department Punjabi University Patiala Punjab 147002 India
Patiala
PUNJAB
147002
India |
| Phone |
8219494595 |
| Fax |
|
| Email |
mehakt768@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mehak |
| Address |
Physiotherapy Department Punjabi University Patiala Punjab 147002 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 |
| Dr Jayaraman G |
Manipal Hospital |
Physiotherapy Department Punjabi University Patiala Punjab 147002 India
Patiala
PUNJAB |
9914889469
jayaraman_mpt@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breath Stacking Technique |
Participants will be positioned in a semi-Fowlers position for the intervention. Instructed to take 3–4 consecutive breaths without exhaling and hold the accumulated breaths as long as possible, followed by slow exhalation through pursed lips. This cycle will be repeated five times per set, with a total of five sets performed. A 30-second rest period will be provided between sets. The total duration of the intervention will be 15 minutes. |
| Comparator Agent |
Pursed-Lip Breathing Technique |
Participants will be seated in a comfortable semi-Fowler’s position for the intervention. They will be instructed to inhale deeply through the nose for approximately 2 seconds, followed by slow exhalation through pursed lips for approximately 4 seconds while controlling airflow. This breathing cycle will be repeated five times per set, with a total of five sets performed. A 30-second rest period will be provided between sets. The total duration of the intervention will be 15 minutes. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients who have undergone laparoscopic hysterectomy and are on Postoperative Day 1-Day 3
Patients with a Glasgow Coma Scale (GCS) score of 13 or above.
Patients who are oriented to time, place, and person. |
|
| ExclusionCriteria |
| Details |
Patients with respiratory distress or acute chest pain.
Patients with chest deformities or previous abdominal surgeries.
Patients with chronic respiratory diseases such as COPD, asthma, tuberculosis, pneumonia,
or pleural effusion.
Hemodynamically unstable patients.
Patients with psychiatric disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oxgenation Saturation,Respiratory Rate,Heart Rate,Blood Pressure. |
Measured before and after the intervention in post-hysterectomy patients. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS)
Borg Scale |
Measured before & After the intervention. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/03/2026 |
| 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="0"
Months="6"
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
|
Laparoscopic hysterectomy is a minimally invasive surgery used to remove the uterus, often performed for conditions such as fibroids and abnormal uterine bleeding. Although the surgery involves small incisions, it is often associated with postoperative factors like anesthesia effects, pain, and reduced mobility. After the procedure, these factors can lead to shallow breathing and reduced lung expansion, which may cause lower oxygen levels. This increases the risk of postoperative complications such as atelectasis. Pursed-lip breathing and breath stacking help in maintaining airway pressure and improving oxygen exchange. Breath stacking maximizes lung expansion and improves ventilation. This study aims to investigate and compare the immediate effects of PLB and BS in patients following laparoscopic hysterectomy. Parameters such as respiratory rate, heart rate, and oxygen saturation will be measured before and after intervention. The goal is to identify which method produces better immediate improvement in oxygenation. |