Sling and Swing Positions to Pregnant Women

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05708482
Collaborator
Eskisehir Osmangazi University (Other)
70
1
2
12
5.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sling-Swing Position
N/A

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:
  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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Effect of Sling and Swing Positions to Pregnant Women in Labour on the Labour Process and Birth Outcomes
Actual Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sling-Swing 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. 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), this applicant will be experienced by them as the same procedure, hourly. A Birth Satisfaction Form will be filled at the 2nd hour after delivery..

Other: Sling-Swing Position
The device is hammock which look likes a rope

No Intervention: Standard Care 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. 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.

Outcome Measures

Primary Outcome Measures

  1. Duration of Labor [during labor process]

    It is about time as a minute

  2. Satisfaction of Labor [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara City Hospital- Maternity Hospital Ankara Çankaya Turkey

Sponsors and Collaborators

  • Ankara City Hospital Bilkent
  • Eskisehir Osmangazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT05708482
Other Study ID Numbers:
  • AnkaraCHBilkent-MH-NK
First Posted:
Feb 1, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ankara City Hospital Bilkent

Study Results

No Results Posted as of Feb 8, 2023