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Completed

NCT Number: NCT07090902

The Effect of Progressive Relaxation Exercise

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsun Training and Research Hospital, Department of Obstetrics and Gynecology

Samsun, Karabük Province, 78500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive Relaxation-Based Childbirth Preparation Program

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.

Other names: PMR-Enhanced Antenatal Program

Primary outcomes

  1. During active labour (at 4-7 cm cervical dilation

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Breastfeeding Comfort

    Time frame: Within 2 hours after delivery (Within 24 hours after delivery)

    Breastfeeding comfort will be evaluated using the Postnatal Comfort Scale

  3. Pain Intensity Score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

Effect of Childbirth Preparation Education Using Progressive Relaxation Exercise on Birth Mode Preference, Labor Pain and Breastfeeding Comfort

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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