- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05708482
Sling and Swing Positions to Pregnant Women
Evaluation of the Effect of Sling and Swing Positions to Pregnant Women in Labour on the Labour Process and Birth Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the sample calculation of the study, the sufficient sample size to be studied with a power of 95% based on d=0.8 (large) effect size alpha=0.05 was calculated using the G*Power 3.1.9.4 program, 35 for the application group and 35 for the control group, a total of 70 people.
According to Robson scoring, the midwife can follow the birth process and Pregnant women who are in the active phase of the first stage of labor (5 cm cervical dilatation) are inclusion criterias.
In the study, data have been collected using Introductory Information and Birth Process Follow-up Form and Postpartum Satisfaction Form were developed by the researchers.
For intervention group:
- While the pregnant woman has 6 cm cervical dilatation examination, the flexible fabric will pass under the arms of the pregnant woman to form a hanger shape. The pregnant woman will be asked to hold the fabric on her feet in a squat and the hanging technique will be applied for 10 minutes. Then, a swing shape will be created in such a way that the flexible fabric will wrap around the chest area of the pregnant woman. The pregnant woman will be asked to hold the fabric in a squat above the knee and the rocking technique will be applied for 10 minutes. The comfort of the pregnant woman will be questioned throughout the procedure. Subsequently, uterine contractions, fetal heart rate, fetal head level, position and presence of molding will be evaluated.
- Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), the pregnant will be held in the hanging position for 10 minutes and rocking position for 10 minutes, once an hour. Uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated after each application, hourly.
For control group:
- While the pregnant woman has 6 cm cervical dilatation examination, uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated.
- Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated every hour.
For Each Group:
A Birth Satisfaction Form will be filled at the 2nd hour after delivery. At the end of the study, delivery times and satisfaction of pregnant women will be analyzed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey
- Ankara City Hospital- Maternity Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- According to Robson scoring, the midwife can follow the birth process.
- Pregnant women who are in the active phase of the first stage of labor
Exclusion Criteria:
- It was decided to deliver by cesarean section due to any indication.
- Pharmacological approach applied
- Any maternal-fetal complication developed
- Those with a height of 150 cm and below
- Pregnant women who want to quit working
- Excluding the inclusion criteria
- Does not know Turkish language (reading-writing-speaking-listening)
- Pregnant women diagnosed with mental and/or auditory disabilities
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: Sling-Swing Group
|
The device is hammock which look likes a rope
|
|
No Intervention: Standard Care Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of Labor
Time Frame: during labor process
|
It is about time as a minute
|
during labor process
|
|
Satisfaction of Labor
Time Frame: postpartum second hour
|
It is about a point which is evaluated by using form.
This simple form was developed by researchers.
It has five state and its maximum point is 25 and minimum point is 5.
The satisfaction increases, the point increases.
|
postpartum second hour
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AnkaraCHBilkent-MH-NK
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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