- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07357246
Breathing Exercises Guided by Student Midwives During Labor (BREATH)
The Effect of Breathing Exercises Applied Under the Guidance of Student Midwives During Birth on Labor Pain, Labor Duration and Birth Satisfaction: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed to evaluate the effect of a midwifery-led intervention on labor pain intensity and birth satisfaction among women giving birth vaginally. The study will be conducted as a controlled clinical study in a maternity hospital setting. Eligible pregnant women who are admitted to the labor ward and meet the inclusion criteria will be invited to participate and will provide informed consent prior to enrollment.
The study aims to determine whether the midwifery-led intervention is associated with reduced labor pain intensity and improved birth satisfaction compared to routine care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Antalya, Turkey (Türkiye), 07190
- Antalya
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18 years and older
Term pregnancy (≥37 weeks of gestation)
Singleton pregnancy
Planning vaginal birth
In the active phase of labor
Able to communicate and provide informed consent
Exclusion Criteria:
- High-risk pregnancy (e.g., preeclampsia, placenta previa, severe medical complications)
Multiple pregnancy
Planned cesarean section
Use of pharmacological pain relief at admission (e.g., epidural analgesia)
Known fetal anomalies
Inability to participate in breathing exercises
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Breathing Exercises Guided by Student Midwives
Participants in this group will receive structured breathing exercises in addition to routine intrapartum care.
The breathing exercises will be guided by trained student midwives from admission to the labor ward until birth.
The intervention will include slow-paced breathing, patterned breathing during contractions, and relaxation-focused breathing between contractions, with continuous guidance and encouragement provided according to a standardized protocol.
|
Structured breathing exercises delivered and monitored by student midwives during labor.
|
|
Active Comparator: Routine Intrapartum Care
Participants in this group will receive routine intrapartum care according to the standard clinical protocols of the maternity hospital.
Routine care includes regular maternal and fetal monitoring, clinical assessment by midwives and obstetric staff, support during labor as per standard practice, and medical or obstetric interventions if clinically indicated.
No structured breathing exercise program will be provided.
|
Standard intrapartum care provided according to hospital protocols.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Labor pain intensity measured by the Visual Analog Scale (VAS) (0-10)
Time Frame: At admission to the labor ward (baseline) and at cervical dilatation of 6-7 cm.
|
Labor pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst pain imaginable."
The outcome will be the VAS score reported by the participant at each assessment time point.
|
At admission to the labor ward (baseline) and at cervical dilatation of 6-7 cm.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Birth satisfaction measured by the Birth Satisfaction Scale Revised (BSS-R)
Time Frame: Within the first 24 hours postpartum
|
Birth satisfaction will be assessed using the Birth Satisfaction Scale-Revised (BSS-R), a 10-item scale with total scores ranging from 0 to 40, where higher scores indicate greater birth satisfaction.
|
Within the first 24 hours postpartum
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seda Serhatlioglu, Doctorate, Antalya Bilim Üniversitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-SS
- 1919B012324751 (Other Grant/Funding Number: TUBITAK 2209-A Undergraduate Research Support Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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