Effect of Childbirth Preparation Education Using Progressive Relaxation Exercise on Birth Mode Preference, Labor Pain and Breastfeeding Comfort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- During active labour (at 4-7 cm cervical dilation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study. No masking is applied to participants, care providers, outcome assessors, or investigators.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Progressive Relaxation-Based Childbirth Preparation Program (Behavioral)
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.
结局指标
主要结局
During active labour (at 4-7 cm cervical dilation
时间窗: 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.
次要结局
- The type of birth and the type of birth they want during pregnancy.(36-38 weeks of pregnancy and within 2 days after birth)
- Pain Intensity Score(within 5 hours after the start of labor)
- Breastfeeding Comfort(Within 2 hours after delivery (Within 24 hours after delivery))
研究者
Reyhan Aydin Doğan
Associate Professor
Karabuk University