NCT07329309

Brief Summary

This study aims to investigate the effect of pranayama breathing exercises on postoperative pain and postpartum comfort levels in women following caesarean section, with the objective of providing important evidence for the integration of non-pharmacological methods into postpartum care.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

February 5, 2026

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

24 days

First QC Date

December 12, 2025

Last Update Submit

February 5, 2026

Conditions

Postoperative Pain

Keywords

caesarean sectionpainpranayamacomfort

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Post-Cesarean Postoperative Pain Intensity

    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 Outcomes (1)

  • Postnatal Comfort Level

    Comfort assessments will be repeated at 6, 12, 24 hours postoperatively in both groups.

Study Arms (2)

Pranayama group

EXPERIMENTAL
Behavioral: pranayama breathing exercises

control group

NO INTERVENTION

Interventions

pranayama breathing exercisesBEHAVIORAL

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.

Pranayama group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum period- ceserian section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kto Karatay University

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

December 12, 2025

First Posted

January 9, 2026

Study Start

February 5, 2026

Primary Completion

March 1, 2026

Study Completion

April 13, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)