The Effect of Progressive Relaxation Exercise

Not Applicable

Recruiting

• Conditions: Breastfeeding; Pregnancy; Labor Pain

• Registration Number: NCT07090902
• Lead Sponsor: Karabuk University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-06-20
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Study Start: 2025-08-25
• Primary Completion: 2025-09-25
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
During active labour (at 4-7 cm cervical dilation	within 5 hours after the start of labor	Labour pain will be assessed using the Visual Analogue Scale (VAS), a 10-point self-reported pain scale. Higher scores indicate more intense pain.

Secondary Outcome Measures

Name	Time	Method
The type of birth and the type of birth they want during pregnancy.	36-38 weeks of pregnancy and within 2 days after birth	The preferred and actual mode of delivery (vaginal vs. caesarean section) will be recorded and compared between intervention and control groups.
Pain Intensity Score	within 5 hours after the start of labor	Pain intensity was measured using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain).
Breastfeeding Comfort	Within 2 hours after delivery (Within 24 hours after delivery)	Breastfeeding comfort will be evaluated using the Postnatal Comfort Scale

Trial Locations

Locations (1)

Samsun Training and Research Hospital, Department of Obstetrics and Gynecology; 🇹🇷 Samsun, Karabük, Turkey