NCT07566026

Brief Summary

This randomized controlled trial evaluated the effects of guided breathing exercises applied during labor on maternal stress, pain, anxiety, birth satisfaction, and labor outcomes. Pregnant women were randomly assigned to a breathing exercise group or a routine care group. Maternal psychological outcomes and labor-related clinical outcomes were compared between groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

February 6, 2026

Last Update Submit

April 30, 2026

Conditions

Labor PainAnxietyStress, Psychological

Keywords

Breathing exercisesLaborBirth satisfactionNon-pharmacological interventionIntrapartum care

Outcome Measures

Primary Outcomes (1)

  • Birth Satisfaction

    Birth satisfaction assessed using the Short Form of the Birth Satisfaction Scale (BSS-R). Scores range from 0 to 40; higher scores indicate greater satisfaction.

    During the fourth stage of labor (within 2 hours after birth).

Secondary Outcomes (5)

  • Labor Pain Intensity

    Repeatedly during labor from admission to the labor unit until delivery.

  • Labor-Related Anxiety

    During the fourth stage of labor (within 2 hours after birth).

  • Traumatic Birth Perception

    At admission to the labor unit (baseline) and during the fourth stage of labor (within 2 hours after birth).

  • Fetal Heart Rate During NST

    During the NST monitoring session (approximately 20 minutes, same visit).

  • Fetal Movement Count During NST

    During the NST monitoring session (approximately 20 minutes, same visit).

Study Arms (2)

Breathing Exercise Group

EXPERIMENTAL

Participants received guided breathing exercises throughout labor in addition to routine intrapartum care.

Behavioral: Guided Breathing Exercises During Labor

Routine Care Group

NO INTERVENTION

Participants received routine intrapartum care only. No breathing exercises were applied.

Interventions

Guided Breathing Exercises During LaborBEHAVIORAL

Pregnant women were instructed and guided to perform slow, controlled breathing exercises during each uterine contraction from the latent phase until full cervical dilatation.

Breathing Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Pregnant women admitted to the labor and delivery unit during the latent phase
  • Women planning vaginal birth
  • Volunteered to participate

You may not qualify if:

  • Women who did not speak Turkish
  • Women with auditory or mental health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nilgün Avcı

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor PainAnxiety DisordersStress, Psychological

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Design

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

Study Record Dates

First Submitted

February 6, 2026

First Posted

May 4, 2026

Study Start

February 1, 2021

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

TU(1)