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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03066973
Other study ID # B.30.2.ATA.0.01.00/69
Secondary ID
Status Completed
Phase N/A
First received February 21, 2017
Last updated March 13, 2017
Start date May 1, 2016
Est. completion date July 30, 2016

Study information

Verified date March 2017
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date July 30, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Nullipar females

- Gestational age 37-42 week

Exclusion Criteria:

- Analgesic and anestezice use

- Clinical instability

- Psychiatric disorders

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BREATHING EXERCISE
The intervention group was instructed on breathing exercise according to the established trial protocol.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Outcome

Type Measure Description Time frame Safety issue
Primary Labor pain It will be measured by Visual Analog Scale (VAS) 1 MONTH
Secondary Duration of labor It will be measured at the second stage of labor as second. 1 MONTH
Secondary APGAR score It will be measured by APGAR score by on-duty pediatrician during assesment at the birth room. 1 MONTH
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