- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329309
Post-Caesarean Pranayama and Pain
The Effect of Post-Caesarean Section Pranayama Breathing Exercises on Pain and Postpartum Comfort: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Konya, Turkey (Türkiye)
- Recruiting
- KTO Karatay University
-
Contact:
- HAFİZE DAĞ TÜZMEN
- Phone Number: 05357446142
- Email: hafizem1992@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergone a caesarean section under spinal anaesthesia
- Reported a post-operative pain level of at least 4 on the Numerical Rating Scale (NRS)
- Knowledge of Turkish
- Ability to communicate effectively with the research team
- Volunteer to participate in the study and provide written consent
Exclusion Criteria:
- Having given birth by emergency caesarean section
- Presence of pregnancy complications (e.g. pre-eclampsia, gestational diabetes, placenta praevia)
- History of chronic pain or analgesic dependence
- Requirement for admission to the intensive care unit in the early postoperative period
- Need for additional surgical intervention
- Development of significant intraoperative or postoperative complications
- Refusal to exercise or intolerance to exercise
- Failure to comply with study procedures
- Withdrawal of consent
- Incomplete follow-up
- Development of a new medical condition during the study that could affect the results
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
|
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Experimental: Pranayama group
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In this study, a pranayama breathing exercise protocol lasting approximately 14-15 minutes will be applied, aiming to increase relaxation and physiological well-being.
Participants will prepare for the exercise in a supported and comfortable sitting position, breathing through the nose.
The protocol consists of 3 minutes of diaphragmatic breathing, 5 minutes of alternate nostril breathing (Nadī Shodhana), 3 minutes of Ujjayi breathing, and 3 minutes of long, slow exhalation techniques.
The exercises will be conducted with one-on-one guidance by a trained researcher; participants' comfort and any signs of discomfort will be monitored, and the exercise will be terminated if necessary.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Post-Cesarean Postoperative Pain Intensity
Time Frame: Pain assessments will be repeated at 6, 12, 24 hours postoperatively in both groups.
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Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line where 0 indicates "no pain" and 10 indicates "worst imaginable/unbearable pain." Higher scores indicate greater pain severity. Pain scores will be recorded at baseline (preoperative) and at predefined postoperative time points. The outcome measure is defined as the change in VAS pain score from baseline.Pain will be assessed with a 10 cm visual analog scale "0" means no pain and "10" means unbearable pain. The assessment will be done before and at the end of the study. |
Pain assessments will be repeated at 6, 12, 24 hours postoperatively in both groups.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postnatal Comfort Level
Time Frame: Comfort assessments will be repeated at 6, 12, 24 hours postoperatively in both groups.
|
Postnatal comfort will be assessed using the Postnatal Comfort Survey, a validated instrument designed to evaluate physical, psychospiritual, sociocultural, and environmental comfort in the postpartum period. Higher scores indicate greater postnatal comfort. Accordingly, the lowest score that can be obtained on the scale is 34, and the highest score is 170. |
Comfort assessments will be repeated at 6, 12, 24 hours postoperatively in both groups.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pranayama
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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