The Effect of Progressive Relaxation Exercise

NCT ID: NCT07090902

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2025-10-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a randomized controlled trial designed to evaluate the effectiveness of a childbirth preparation education program that incorporates progressive relaxation exercises. The intervention was developed to address the physical and psychological challenges pregnant women face, particularly in managing labour pain, making informed decisions about mode of delivery, and achieving comfort in early breastfeeding.

The study will be conducted in four stages. First, a childbirth preparation booklet including progressive relaxation techniques will be created based on current literature and expert guidance. Second, the content will be reviewed by a panel of experts to ensure content validity. Third, eligible pregnant women will receive in-person training sessions supported by the booklet and a relaxation exercise CD developed by the Turkish Psychological Association. Lastly, participants will be instructed to practice the exercises daily at home, and the effectiveness of the intervention will be evaluated using validated measurement tools.

The trial will be conducted in Samsun, Türkiye, and will include 40 pregnant women meeting specific inclusion criteria. Participants will be randomly assigned to either the intervention group or the control group. Outcomes will be measured using established scales such as the Visual Analogue Scale (VAS) for labour pain, LATCH for breastfeeding, and a postpartum comfort scale. The results of this study may contribute to the development of accessible, low-cost, and culturally appropriate childbirth education strategies in Türkiye and globally.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breastfeeding Pregnancy Labor Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

This is an open-label study. No masking is applied to participants, care providers, outcome assessors, or investigators.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Progressive Relaxation-Based Childbirth Preparation Program

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.

Group Type EXPERIMENTAL

Progressive Relaxation-Based Childbirth Preparation Program

Intervention Type BEHAVIORAL

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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Progressive Relaxation-Based Childbirth Preparation Program

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PMR-Enhanced Antenatal Program

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karabuk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Reyhan Aydin Doğan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Samsun Training and Research Hospital, Department of Obstetrics and Gynecology

Samsun, Karabük Province, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 26656473 (View on PubMed)

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.

Reference Type RESULT
PMID: 32379667 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KBÜBAP-24-YL-010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023/1493

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.