Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05708482 |
Other study ID # |
AnkaraCHBilkent-MH-NK |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 30, 2022 |
Est. completion date |
September 30, 2023 |
Study information
Verified date |
December 2023 |
Source |
Ankara City Hospital Bilkent |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
It is an experimental and randomized controlled study planned to evaluate the effect of
sling-swinging position on the birth experience in vaginal delivery.
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:
1. 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.
2. 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:
1. 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.
2. 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.