NCT07357246

Brief Summary

This randomized controlled trial aimed to evaluate the effect of breathing exercises applied under the guidance of student midwives during labor on labor pain, labor duration, and birth satisfaction. The intervention group received structured breathing exercises guided by student midwives throughout labor, while the control group received routine intrapartum care. Outcomes were assessed during labor and in the early postpartum period

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 2, 2026

Last Update Submit

February 1, 2026

Conditions

Keywords

Breathing ExercisesLabor PainStudent MidwivesBirth SatisfactionLabor DurationMidwifery Care

Outcome Measures

Primary Outcomes (1)

  • Labor pain intensity measured by the Visual Analog Scale (VAS) (0-10)

    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 Outcomes (1)

  • Birth satisfaction measured by the Birth Satisfaction Scale Revised (BSS-R)

    Within the first 24 hours postpartum

Study Arms (2)

Breathing Exercises Guided by Student Midwives

EXPERIMENTAL

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.

Behavioral: Guided Breathing Exercises During Labor

Routine Intrapartum Care

ACTIVE COMPARATOR

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.

Other: Routine Intrapartum Care

Interventions

Structured breathing exercises delivered and monitored by student midwives during labor.

Breathing Exercises Guided by Student Midwives

Standard intrapartum care provided according to hospital protocols.

Routine Intrapartum Care

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya

Antalya, 07190, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seda Serhatlioglu, Doctorate

    Antalya Bilim Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 21, 2026

Study Start

September 1, 2024

Primary Completion

March 3, 2025

Study Completion

March 15, 2025

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared.

Locations