NCT07090902

Brief Summary

This clinical trial aims to evaluate the effect of a childbirth preparation program that includes progressive relaxation exercises on pregnant women's preferences for mode of delivery, their experience of labour pain, and breastfeeding comfort. Participants in the intervention group will receive a specially developed educational booklet and an audio CD with guided exercises, along with face-to-face training sessions. The control group will receive standard prenatal care. The study will help determine whether relaxation-based training can support women in coping with labour more comfortably and influence their choices and early postpartum experiences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

June 20, 2025

Last Update Submit

January 18, 2026

Conditions

Keywords

Progressive relaxation exerciselabor paindelivery methodbreastfeeding

Outcome Measures

Primary Outcomes (1)

  • During active labour (at 4-7 cm cervical dilation

    Labour pain will be assessed using the Visual Analogue Scale (VAS), a 10-point self-reported pain scale. Higher scores indicate more intense pain.

    within 5 hours after the start of labor

Secondary Outcomes (3)

  • The type of birth and the type of birth they want during pregnancy.

    36-38 weeks of pregnancy and within 2 days after birth

  • Breastfeeding Comfort

    Within 2 hours after delivery (Within 24 hours after delivery)

  • Pain Intensity Score

    within 5 hours after the start of labor

Study Arms (2)

Progressive Relaxation-Based Childbirth Preparation Program

EXPERIMENTAL

A structured education program including progressive muscle relaxation techniques delivered through face-to-face instruction, printed materials, and a guided CD. Participants are asked to follow daily exercises at home until birth.

Behavioral: Progressive Relaxation-Based Childbirth Preparation Program

Control Group

NO INTERVENTION

Participants in this group will receive standard antenatal care provided by the hospital. No additional childbirth education or relaxation training will be offered.

Interventions

This intervention consists of a childbirth preparation program that integrates progressive muscle relaxation (PMR) exercises. Participants receive face-to-face education by trained health professionals, a printed booklet explaining both childbirth preparation and PMR techniques, and an audio CD with guided relaxation sessions produced by the Turkish Psychological Association. The participants are instructed to perform the relaxation exercises daily at home until delivery. The goal of this intervention is to reduce labour pain, support informed mode of delivery preference, and enhance breastfeeding comfort in the early postpartum period.

Also known as: PMR-Enhanced Antenatal Program
Progressive Relaxation-Based Childbirth Preparation Program

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female participants aged between 18 and 49 years
  • Currently pregnant
  • Willing to participate in the study and provide informed consent
  • Able to attend the planned training sessions regularly
  • No complications during pregnancy, childbirth, or postpartum for themselves or their newborn

You may not qualify if:

  • Not within the age range of 18-49
  • Not currently pregnant
  • Fails to complete study questionnaires or withdraws from the study
  • Has communication difficulties or cognitive impairment
  • Fails to attend training sessions regularly
  • Has open wounds or allergic skin conditions
  • Develops postpartum complications (e.g., bleeding, infection, fever)
  • Has cardiac arrhythmia or uses a pacemaker
  • Diagnosed with conditions such as epilepsy or pre-eclampsia
  • Has kidney or liver disease
  • Previously practiced progressive muscle relaxation techniques
  • Is morbidly obese (BMI \> 40)
  • Uses chronic opioids, antidepressants, or psychoactive medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Training and Research Hospital, Department of Obstetrics and Gynecology

Samsun, Karabük Province, 78500, Turkey (Türkiye)

Location

Related Publications (2)

  • Sercekus P, Baskale H. Effects of antenatal education on fear of childbirth, maternal self-efficacy and parental attachment. Midwifery. 2016 Mar;34:166-172. doi: 10.1016/j.midw.2015.11.016. Epub 2015 Nov 27.

  • Liu K, Chen Y, Wu D, Lin R, Wang Z, Pan L. Effects of progressive muscle relaxation on anxiety and sleep quality in patients with COVID-19. Complement Ther Clin Pract. 2020 May;39:101132. doi: 10.1016/j.ctcp.2020.101132. Epub 2020 Mar 6.

MeSH Terms

Conditions

Breast FeedingLabor Pain

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. No masking is applied to participants, care providers, outcome assessors, or investigators.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a parallel-group, randomized controlled trial with two arms: one intervention group receiving childbirth preparation training with progressive relaxation exercises, and one control group receiving standard prenatal care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 20, 2025

First Posted

July 29, 2025

Study Start

August 25, 2025

Primary Completion

September 25, 2025

Study Completion

October 20, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations