NCT03066973

Brief Summary

This study aimed to assess the efficacy of breathing exercises (BE) during the second stage of labor for maternal pain, duration of labor and first-minute APGAR score. This is a randomized controlled trial that compares nulliparous pregnant in the second stage of labor instructed regarding BE with a control group (CG) that received standard care service. It was conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum. One session of BE training were given to pregnant in intervention group (IG). Visual Analog Scale (VAS) was performed to identify perception of pain to all pregnant during the second stage of birth. Time of the second stage was recorded as second (sec), and first minute APGAR scores were recorded. Significance was set at p\<0.05.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

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

May 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

February 21, 2017

Last Update Submit

March 13, 2017

Conditions

Keywords

breath exerciseslabor painlabor durationVAS

Outcome Measures

Primary Outcomes (1)

  • Labor pain

    It will be measured by Visual Analog Scale (VAS)

    1 MONTH

Secondary Outcomes (2)

  • Duration of labor

    1 MONTH

  • APGAR score

    1 MONTH

Study Arms (2)

Intervention group

EXPERIMENTAL

The trial compares nulliparous pregnant in the second stage of labor instructed regarding breathing exercise with a control group that received standard care service.

Behavioral: BREATHING EXERCISE

Control group

NO INTERVENTION

control group that received standard care service.

Interventions

The intervention group was instructed on breathing exercise according to the established trial protocol.

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsnullipar females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nullipar females
  • Gestational age 37-42 week

You may not qualify if:

  • Analgesic and anestezice use
  • Clinical instability
  • Psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yuksel H, Cayir Y, Kosan Z, Tastan K. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: a randomized controlled trial. J Integr Med. 2017 Nov;15(6):456-461. doi: 10.1016/S2095-4964(17)60368-6.

MeSH Terms

Conditions

Labor Pain

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 21, 2017

First Posted

March 1, 2017

Study Start

May 1, 2016

Primary Completion

June 30, 2016

Study Completion

July 30, 2016

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

it will be submitted as an article