- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03066973
BREATHING EXERCISES FOR LABOR PAIN AND DURATION
March 13, 2017 updated by: Yasemin Cayir, Ataturk University
THE EFFECTIVENESS OF BREATHING EXERCISES TO LABOR PAIN and DURATION: A RANDOMIZED CONTROLLED TRIAL
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this trial, it is aimed to assess the effectiveness of breathing exercises (BE) for management of labor pain during the second stage of labor.
Nulliparous pregnant were randomized two arms.
Intervention group received breathing exercise at the first stage of labor.
Control group received routine care services.
It was conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum, Turkey.
Visual Analog Scale (VAS) was performed to identify perception of pain to all pregnant during the second stage of labor.
Time of the second stage was recorded as second (sec), and first minute APGAR scores of newborn were recorded.
All analysis was carried out using SPSS 20.
Significance was set at p<0.05.
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Nullipar females
- Gestational age 37-42 week
Exclusion Criteria:
- Analgesic and anestezice use
- Clinical instability
- Psychiatric disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Intervention group
The trial compares nulliparous pregnant in the second stage of labor instructed regarding breathing exercise with a control group that received standard care service.
|
The intervention group was instructed on breathing exercise according to the established trial protocol.
|
No Intervention: Control group
control group that received standard care service.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Labor pain
Time Frame: 1 MONTH
|
It will be measured by Visual Analog Scale (VAS)
|
1 MONTH
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of labor
Time Frame: 1 MONTH
|
It will be measured at the second stage of labor as second.
|
1 MONTH
|
APGAR score
Time Frame: 1 MONTH
|
It will be measured by APGAR score by on-duty pediatrician during assesment at the birth room.
|
1 MONTH
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
June 30, 2016
Study Completion (Actual)
July 30, 2016
Study Registration Dates
First Submitted
February 21, 2017
First Submitted That Met QC Criteria
February 24, 2017
First Posted (Actual)
March 1, 2017
Study Record Updates
Last Update Posted (Actual)
March 14, 2017
Last Update Submitted That Met QC Criteria
March 13, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ATA.0.01.00/69
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
it will be submitted as an article
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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