Postoperative PainNCT07329309
Post-Caesarean Pranayama and Pain
A study testing pranayama breathing exercises in people with Postoperative Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- pranayama breathing exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2026to 13 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kto Karatay University
Konya, Konya
HAFİZE DAĞ TÜZMEN, 05357446142, hafizem1992@gmail.com
About this study
Official title: The Effect of Post-Caesarean Section Pranayama Breathing Exercises on Pain and Postpartum Comfort: A Randomised Controlled Trial
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.
- Conditions
- Postoperative Pain
- Being tested
- pranayama breathing exercises
- Keywords
- caesarean section, pain, pranayama, comfort
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pranayama breathing exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pranayama group | Experimental | Not described Receives: Behavioral: pranayama breathing exercises |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pain assessments will be repeated at 6, 12, 24 hours postoperatively in both groups.
Secondary outcomes (1)
Postnatal Comfort Level
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.
Measured: Comfort assessments will be repeated at 6, 12, 24 hours postoperatively in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start5 Feb 2026
- Primary completion16 Aug 2026
- Study completion13 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafize Dağ Tüzmen, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329309
- Sponsor's protocol ID
- Pranayama
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Post-Caesarean Section Pranayama Breathing Exercises on Pain and Postpartum Comfort: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07329309
- Acronym / sponsor ID
- Pranayama
- Conditions
- Postoperative Pain
- Keywords
- caesarean section, pain, pranayama, comfort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 16 Aug 2026 (actual)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pranayama group | Experimental | Behavioral: pranayama breathing exercises |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pranayama breathing exercisesIn 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. | Behavioural | Pranayama group |
Primary outcome
Change from Baseline Post-Cesarean Postoperative Pain Intensity
Time frame: Pain assessments will be repeated at 6, 12, 24 hours postoperatively in both groups.
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.
1 secondary outcome
Postnatal Comfort Level
Time frame: Comfort assessments will be repeated at 6, 12, 24 hours postoperatively in both groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pranayama breathing exercises in people with Postoperative Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Post-Cesarean Postoperative Pain Intensity (time frame: Pain assessments will be repeated at 6, 12, 24 hours postoperatively in both groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.