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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Eyalet/Yerleşke
      • Şanlıurfa, Eyalet/Yerleşke, Turkey, 63000
        • Recruiting
        • Sanlıurfa Training and Research Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control
control group
Experimental: yoga nidra
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aysegul Kilicli

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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