- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06070844
Yoga Nidra and Pain After Caesarean Section
October 13, 2023 updated by: Aysegul Kilicli
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
Study Overview
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 Type
Interventional
Enrollment (Estimated)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: AYŞEGÜL KILIÇLI
- Phone Number: (0414) 317 17 17
- Email: aysegul_ay_9@hotmail.com
Study Locations
-
-
Eyalet/Yerleşke
-
Şanlıurfa, Eyalet/Yerleşke, Turkey, 63000
- Recruiting
- Şanlıurfa training and research hospital
-
Contact:
- AYŞEGÜL KILIÇLI
- Phone Number: (0414) 317 17 17
- Email: aysegul_ay_9@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
control group
|
|
Experimental: yoga nidra
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
immediately before yoga nidra application
|
Cesarean Pain
Time Frame: immediately after yoga nidra application
|
Visual Analogue Scale for Pain
|
immediately after yoga nidra application
|
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.
|
immediately after yoga nidra application
|
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.
|
immediately after yoga nidra application
|
Patient Satisfaction
Time Frame: immediately after yoga nidra application
|
Newcastle Satisfaction with Nursing Care Scale
|
immediately after yoga nidra application
|
Walking distance
Time Frame: immediately after yoga nidra application
|
The first walking distance of the mothers will be measured with a meter.
|
immediately after yoga nidra application
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Estimated)
November 30, 2023
Study Completion (Estimated)
November 30, 2023
Study Registration Dates
First Submitted
September 18, 2023
First Submitted That Met QC Criteria
September 30, 2023
First Posted (Actual)
October 6, 2023
Study Record Updates
Last Update Posted (Actual)
October 17, 2023
Last Update Submitted That Met QC Criteria
October 13, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- yoga nidra and caesarean
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Caesarean Section
-
Assiut UniversityUnknownCaesarean SectionEgypt
-
Taipei Medical University WanFang HospitalCompletedCaesarean SectionTaiwan
-
Sintetica SACross Research S.A.TerminatedUnplanned Caesarean SectionBelgium
-
Egyptian Society of Royal College of Obstetricians...UnknownCaesarean Section RateEgypt
-
Shanghai First Maternity and Infant HospitalUnknownCaesarean SectionChina
-
Maimonides Medical CenterTerminatedCaesarean SectionUnited States
-
Maastricht University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentUnknownCaesarean SectionNetherlands
-
Minia UniversityCompletedCaesarean Section Rate | EgyptEgypt
-
Trakya UniversityCompletedCaesarean Section | Anesthesia; Reaction
Clinical Trials on yoga nidra
-
Samueli Institute for Information BiologyWalter Reed Army Medical CenterCompleted
-
National University of Natural MedicineUniversity of Manitoba; Oregon Health and Science UniversityCompletedElectrocardiography | Electroencephalography | Respiratory Rate | Surveys and QuestionnairesUnited States
-
National University of Natural MedicineCompleted
-
National University of Natural MedicineUS Department of Veterans AffairsNot yet recruitingInsomnia | Anxiety
-
Universität Duisburg-EssenCompleted
-
University of Texas at AustinCompleted
-
Adiyaman University Research HospitalCompletedDepression | Stress | Anxiety | Psychological ResilienceTurkey
-
NMP Medical Research InstituteYog-Kulam; Department of Zoology, University of Rajasthan, IndiaCompleted
-
NMP Medical Research InstituteWarwick Research Services; Yog-KulamCompleted
-
Northwestern UniversityCompleted