NCT06070844

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

September 18, 2023

Last Update Submit

October 13, 2023

Conditions

Caesarean SectionYoga

Keywords

caesarean sectionyoga nidrapainmobilization

Outcome Measures

Primary Outcomes (6)

  • Cesarean Pain

    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

    Visual Analogue Scale for Pain

    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.

    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.

    immediately after yoga nidra application

  • Patient Satisfaction

    Newcastle Satisfaction with Nursing Care Scale

    immediately after yoga nidra application

  • Walking distance

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

    immediately after yoga nidra application

Study Arms (2)

yoga nidra

EXPERIMENTAL

yoga nidra

Behavioral: yoga nidra

control

NO INTERVENTION

control group

Interventions

yoga nidraBEHAVIORAL

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.

yoga nidra

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmothers giving birth only by caesarean section in hospital
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şanlıurfa training and research hospital

Sanliurfa, Eyalet/Yerleşke, 63000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

AYŞEGÜL KILIÇLI

CONTACT

(0414) 317 17 17aysegul_ay_9@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gaziantep University Health Sciences Institute, Department of Nursing, Department of Obstetrics and Gynaecology Nursing, PhD.

Study Record Dates

First Submitted

September 18, 2023

First Posted

October 6, 2023

Study Start

October 1, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)