Caesarean SectionNCT06070844
Yoga Nidra and Pain After Caesarean Section
A study testing yoga nidra in people with Caesarean Section and Yoga, run by Aysegul Kilicli at 1 site in Turkey (Türkiye).
Trial summary
The effect of yoga nidra on pain, mobilisation, first walking distance and maternal satisfaction after caesarean section Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section, Yoga
- What is being tested?
- yoga nidra
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women who gave birth by caesarean section,
- whose birth was performed with spinal anaesthesia,
- who are 19 years of age or older and 35 years of age or younger,
- who were born at 37 or more weeks of gestation,
- who had a singleton birth,
- who do not have chronic diseases and any complications in this pregnancy and postpartum period,
- who have not performed yoga nidra practice before will be included in the study.
Who cannot join
- those who do not meet the inclusion criteria of the study,
- who do not voluntarily participate in the study,
- those who want to voluntarily leave the study at any stage after being included in the study,
- mothers who develop any health problems in the birth and postpartum period will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Şanlıurfa training and research hospital
Sanliurfa, Eyalet/Yerleşke, 63000
AYŞEGÜL KILIÇLI, (0414) 317 17 17, aysegul_ay_9@hotmail.com
About this study
Official title: The Effect of Yoga Nidra on Pain, Mobility, First Walking Distance and Maternal Satisfaction After Caesarean Section
The effect of yoga nidra on pain, mobilisation, first walking distance and maternal satisfaction after caesarean section
Read the detailed description
The aim of this study is to investigate the effect of yoga nidra on pain, mobilisation, first walking distance and maternal satisfaction after caesarean section.
Sample size:
- The sample size is 128 women.
- The sample will include 64 mothers in the experimental group and 64 mothers in the control group.
Application time:
- Yoga nidra will be performed once in the sixth postoperative hour after caesarean section.
- Yoga nidra will be carried out once for each mother by the researcher Ayşegül Kılıçlı.
- The application will take 30 minutes.
- Only yoga nidra will not be applied to the control group. Other measurements and follow-ups will be carried out in parallel as in the experimental group.
Data collection tools:
- Introductory Information Form
- Visual Analogue Scale for Pain
- Patient Mobility Scale and Observer Mobility Scale
- Newcastle Satisfaction with Nursing Care Scale
- Note: Mobilisation distance will be measured with a metre.
Measurement time:
- Introductory Information Form will be filled out before application.
- Pain level will be measured immediately before the application.
- immediately after the application pain, mobilisation, first walking distance and maternal satisfaction will be measured.
- Conditions
- Caesarean Section, Yoga
- Being tested
- yoga nidra
- Keywords
- caesarean section, yoga nidra, pain, mobilization
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga nidraBehavioural
Yoga Nidra is a guided meditation technique that involves listening to audio readings. Yoga nidra application will be started at the 6th postoperative hour and will be applied one time. Yoga nidra is expressed as yoga sleep or deep relaxation. In this practice, it will be ensured that the mother will mentally visualise all parts of her body with the commands to be given during controlled breathing and emotionally feel the body parts. The Yoga Nidra application will last 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| yoga nidra | Experimental | yoga nidra Receives: Behavioral: yoga nidra |
| control | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean Pain
Visual Analogue Scale for Pain; It scores between 0 and 10, and the higher the score, the greater the pain.
Measured: immediately before yoga nidra application
Cesarean Pain
Visual Analogue Scale for Pain
Measured: immediately after yoga nidra application
Patient Mobilization
Patient Mobility Scale; The lowest and highest score that can be obtained from each item is between 0-15, and the total score is between 0-120. An increase in scale scores for the question answers in the study indicates an increase in pain and stiffness related to activity.
Measured: immediately after yoga nidra application
Observer Mobilization
Observer Mobility Scale; The lowest and highest score that can be obtained from each item of the scale is between 1-5, and the total score is between 4-20. An increase in the score indicates insufficient mobility.
Measured: immediately after yoga nidra application
Patient Satisfaction
Newcastle Satisfaction with Nursing Care Scale
Measured: immediately after yoga nidra application
Walking distance
The first walking distance of the mothers will be measured with a meter.
Measured: immediately after yoga nidra application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Oct 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aysegul Kilicli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysegul Kilicli, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070844
- Sponsor's protocol ID
- yoga nidra and caesarean
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga Nidra on Pain, Mobility, First Walking Distance and Maternal Satisfaction After Caesarean Section
- ClinicalTrials.gov ID
- NCT06070844
- Acronym / sponsor ID
- yoga nidra and caesarean
- Conditions
- Caesarean Section, Yoga
- Keywords
- caesarean section, yoga nidra, pain, mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Aysegul KilicliUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 6 Oct 2023 (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.
The effect of yoga nidra on pain, mobilisation, first walking distance and maternal satisfaction after caesarean section
Detailed description
The aim of this study is to investigate the effect of yoga nidra on pain, mobilisation, first walking distance and maternal satisfaction after caesarean section.
Sample size:
- The sample size is 128 women.
- The sample will include 64 mothers in the experimental group and 64 mothers in the control group.
Application time:
- Yoga nidra will be performed once in the sixth postoperative hour after caesarean section.
- Yoga nidra will be carried out once for each mother by the researcher Ayşegül Kılıçlı.
- The application will take 30 minutes.
- Only yoga nidra will not be applied to the control group. Other measurements and follow-ups will be carried out in parallel as in the experimental group.
Data collection tools:
- Introductory Information Form
- Visual Analogue Scale for Pain
- Patient Mobility Scale and Observer Mobility Scale
- Newcastle Satisfaction with Nursing Care Scale
- Note: Mobilisation distance will be measured with a metre.
Measurement time:
- Introductory Information Form will be filled out before application.
- Pain level will be measured immediately before the application.
- immediately after the application pain, mobilisation, first walking distance and maternal satisfaction will be measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| yoga nidra | Experimental | Behavioral: yoga nidrayoga nidra |
| control | No intervention | –control group |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- women who gave birth by caesarean section,
- whose birth was performed with spinal anaesthesia,
- who are 19 years of age or older and 35 years of age or younger,
- who were born at 37 or more weeks of gestation,
- who had a singleton birth,
Key exclusion criteria (4 listed)
- those who do not meet the inclusion criteria of the study,
- who do not voluntarily participate in the study,
- those who want to voluntarily leave the study at any stage after being included in the study,
- mothers who develop any health problems in the birth and postpartum period will be excluded.
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 |
|---|---|---|
| yoga nidraYoga Nidra is a guided meditation technique that involves listening to audio readings. Yoga nidra application will be started at the 6th postoperative hour and will be applied one time. Yoga nidra is expressed as yoga sleep or deep relaxation. In this practice, it will be ensured that the mother will mentally visualise all parts of her body with the commands to be given during controlled breathing and emotionally feel the body parts. The Yoga Nidra application will last 30 minutes. | Behavioural | yoga nidra |
Primary outcome
Cesarean Pain
Time frame: immediately before yoga nidra application
Visual Analogue Scale for Pain; It scores between 0 and 10, and the higher the score, the greater the pain.
Cesarean Pain
Time frame: immediately after yoga nidra application
Visual Analogue Scale for Pain
Patient Mobilization
Time frame: immediately after yoga nidra application
Patient Mobility Scale; The lowest and highest score that can be obtained from each item is between 0-15, and the total score is between 0-120. An increase in scale scores for the question answers in the study indicates an increase in pain and stiffness related to activity.
Observer Mobilization
Time frame: immediately after yoga nidra application
Observer Mobility Scale; The lowest and highest score that can be obtained from each item of the scale is between 1-5, and the total score is between 4-20. An increase in the score indicates insufficient mobility.
Patient Satisfaction
Time frame: immediately after yoga nidra application
Newcastle Satisfaction with Nursing Care Scale
Walking distance
Time frame: immediately after yoga nidra application
The first walking distance of the mothers will be measured with a meter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga nidra in people with Caesarean Section and Yoga, run by Aysegul Kilicli 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AYŞEGÜL KILIÇLI ((0414) 317 17 17, aysegul_ay_9@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean Pain (time frame: immediately before yoga nidra application). The study lists 6 primary outcomes in all. 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 17 Oct 2023.