Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT07090902
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Progressive Relaxation Exercise
Sponsor:
Karabuk University
Organization:
Study Overview
Official Title:
Effect of Childbirth Preparation Education Using Progressive Relaxation Exercise on Birth Mode Preference, Labor Pain and Breastfeeding Comfort
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| KBÜBAP-24-YL-010 | OTHER_GRANT | karabük üniversity | View |