Back to resultsBREATHING EXERCISES FOR LABOR PAIN AND DURATION
Primary Purpose
Labor Pain, Breathing Exercise
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BREATHING EXERCISE
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain focused on measuring breath exercises, labor pain, labor duration, VAS
Eligibility Criteria
Inclusion Criteria:
- Nullipar females
- Gestational age 37-42 week
Exclusion Criteria:
- Analgesic and anestezice use
- Clinical instability
- Psychiatric disorders
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
The trial compares nulliparous pregnant in the second stage of labor instructed regarding breathing exercise with a control group that received standard care service.
control group that received standard care service.
Outcomes
Primary Outcome Measures
Labor pain
It will be measured by Visual Analog Scale (VAS)
Secondary Outcome Measures
Duration of labor
It will be measured at the second stage of labor as second.
APGAR score
It will be measured by APGAR score by on-duty pediatrician during assesment at the birth room.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03066973
Brief Title
BREATHING EXERCISES FOR LABOR PAIN AND DURATION
Official Title
THE EFFECTIVENESS OF BREATHING EXERCISES TO LABOR PAIN and DURATION: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
July 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Breathing Exercise
Keywords
breath exercises, labor pain, labor duration, VAS
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The trial compares nulliparous pregnant in the second stage of labor instructed regarding breathing exercise with a control group that received standard care service.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
control group that received standard care service.
Intervention Type
Behavioral
Intervention Name(s)
BREATHING EXERCISE
Intervention Description
The intervention group was instructed on breathing exercise according to the established trial protocol.
Primary Outcome Measure Information:
Title
Labor pain
Description
It will be measured by Visual Analog Scale (VAS)
Time Frame
1 MONTH
Secondary Outcome Measure Information:
Title
Duration of labor
Description
It will be measured at the second stage of labor as second.
Time Frame
1 MONTH
Title
APGAR score
Description
It will be measured by APGAR score by on-duty pediatrician during assesment at the birth room.
Time Frame
1 MONTH
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
nullipar females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Nullipar females
Gestational age 37-42 week
Exclusion Criteria:
Analgesic and anestezice use
Clinical instability
Psychiatric disorders
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
it will be submitted as an article
Citations:
PubMed Identifier
29103415
Citation
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.
Results Reference
derived
Learn more about this trial
BREATHING EXERCISES FOR LABOR PAIN AND DURATION
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