Yoga Nidra and Pain After Caesarean Section

• Sponsor: Aysegul Kilicli (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06070844
• Collaborator: (none)
• Enrollment: 128
• Arms: 2
• Anticipated Duration (Months): 2

Study Details

Study Description

Brief Summary

The effect of yoga nidra on pain, mobilisation, first walking distance and maternal satisfaction after caesarean section

Condition or Disease	Intervention/Treatment	Phase
Caesarean Section; Yoga	Behavioral: yoga nidra	N/A

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.

Randomization:

• Participants will be randomly assigned to the experimental and control groups.

• 64 pieces of experimental and 64 pieces of control papers will be placed in closed opaque envelopes and mixed in a bag.

• Participant mothers will be asked to draw an envelope from this bag. The information in the envelope will not be shared with the participant mothers.

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

• Study Type: Interventional
• Anticipated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomised controlled trialrandomised controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Yoga Nidra on Pain, Mobility, First Walking Distance and Maternal Satisfaction After Caesarean Section
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: yoga nidra 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.
No Intervention: control control group

Outcome Measures

Primary Outcome Measures

1. Cesarean Pain [immediately before application]

   Visual Analogue Scale for Pain

2. Cesarean Pain [immediately after application]

   Visual Analogue Scale for Pain

3. Patient Mobilization [immediately after application]

   Patient Mobility Scale

4. Observer Mobilization [immediately after application]

   Observer Mobility Scale

5. Patient Satisfaction [immediately after application]

   Newcastle Satisfaction with Nursing Care Scale

6. Walking distance [immediately after application]

   The first walking distance of the mothers will be measured with a meter.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aysegul Kilicli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aysegul Kilicli, Gaziantep University Health Sciences Institute, Department of Nursing, Department of Obstetrics and Gynaecology Nursing, PhD., University of Gaziantep
• ClinicalTrials.gov Identifier: NCT06070844
• Other Study ID Numbers: yoga nidra and caesarean
• First Posted: Oct 6, 2023
• Last Update Posted: Oct 6, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aysegul Kilicli, Gaziantep University Health Sciences Institute, Department of Nursing, Department of Obstetrics and Gynaecology Nursing, PhD., University of Gaziantep: caesarean section; yoga nidra; pain; mobilization

Study Results

No Results Posted as of Oct 6, 2023