- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07446699
The Effect of Pushing Techniques Used During Childbirth on Women's Labor Duration, Pain, and Fatigue Levels
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Sivas, Turkey (Türkiye), 58140
- Sivas Cumhuriyet University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 19-35 years old
- Having had a normal vaginal delivery,
- Being between 38-41 weeks pregnant,
- Having a cervical dilation of 8 cm or more,
- Being nulliparous,
- Having a singleton pregnancy,
- Not having a diagnosed physical health problem in the fetus or mother,
- Not having a diagnosed mental health problem in the mother,
- Not having hearing or perception problems,
- Volunteering to participate in the study.
Exclusion Criteria:
- Being under 19 or over 35 years of age,
- Having undergone a planned cesarean section,
- Being gestational age between 38 and 41 weeks,
- Cervical dilation less than 8 cm,
- Being multiparous,
- Having a multiple pregnancy,
- Having a diagnosed physical health problem in the fetus or mother,
- Having a diagnosed mental health problem in the mother,
- Having hearing and perception problems,
- Not being a volunteer to participate in the study.
Study Plan
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: Spontaneous pushing group
This is the type of pushing that a pregnant woman does by making sounds and exhaling.
The pregnant woman pushes spontaneously, and the intensity of the push is consistent with the contractions.
Although contractions occur during spontaneous pushing, the pregnant woman does not push until she feels the urge to push.
Pushing occurs with the urge to push.
The pregnant woman begins to push with her resting breath.
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In this pushing method, pregnant women remain in a squatting position during the second stage of labor. The researcher provides the women with information about spontaneous pushing. The women will be supported in spontaneous pushing, and their urge to push will be taken into consideration. In spontaneous pushing: Regular breathing until the urge to push is felt when contractions begin, inhaling and contracting the core muscles, pushing slowly, exhaling smoothly while contracting during pushing, pushing for 5-6 seconds while exhaling, pushing smoothly and regularly for 5-6 seconds while inhaling and exhaling, and regular breathing when contractions slow down. |
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Experimental: Valsalva straining group
This is the type of pushing performed by the pregnant woman while holding her breath.
This type of pushing is generally considered by healthcare professionals as directed pushing.
The researcher will guide the woman on when and how to push.
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|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: Baseline
|
It is used to assess pain intensity.
The scale is graded from 0 to 10 cm in length, where 0 represents no pain and 10 represents the most severe pain.
It is applied by having the individual mark a point corresponding to the intensity of the pain they feel.
The distance between the marked point and the lowest end of the line is measured in centimeters, and the resulting numerical value indicates the patient's pain intensity.
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Baseline
|
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Visual Similarity Scale for Fatigue
Time Frame: Baseline
|
The Visual Analogy Scale for Fatigue consists of 18 items.
13 items form the fatigue subscale, and five items form the energy subscale.
The most positive and the most negative statements are located at opposite ends of the scale, and horizontal lines with 10 cm intervals are placed between the two statements.
A high score on the fatigue subscale and a low score on the energy subscale indicate a higher intensity of fatigue.
The minimum score for the fatigue subscale was 0, and the maximum score was 130; the minimum score for the energy subscale was 0, and the maximum score was 50.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: In the fourth stage of labor
|
It is used to assess pain intensity.
The scale is graded from 0 to 10 cm in length, where 0 represents no pain and 10 represents the most severe pain.
It is applied by having the individual mark a point corresponding to the intensity of the pain they feel.
The distance between the marked point and the lowest end of the line is measured in centimeters, and the resulting numerical value indicates the patient's pain intensity.
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In the fourth stage of labor
|
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Visual Analogy Scale for Fatigue
Time Frame: In the fourth stage of labor
|
The Visual Analogy Scale for Fatigue consists of 18 items.
13 items form the fatigue subscale, and five items form the energy subscale.
The most positive and the most negative statements are located at opposite ends of the scale, and horizontal lines with 10 cm intervals are placed between the two statements.
A high score on the fatigue subscale and a low score on the energy subscale indicate a higher intensity of fatigue.
The minimum score for the fatigue subscale was 0, and the maximum score was 130; the minimum score for the energy subscale was 0, and the maximum score was 50.
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In the fourth stage of labor
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sukran Ertekin Pinar, Prof. Dr., Cumhuriyet University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TR SİVAS 09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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