Sling and Swing Positions to Pregnant Women

NCT ID: NCT05708482

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-09-30

Brief Summary

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It is an experimental and randomized controlled study planned to evaluate the effect of sling-swinging position on the birth experience in vaginal delivery.

Detailed Description

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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.

Conditions

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Labor Parturition Delivery

Keywords

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delivery duration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Sling-Swing Position

Intervention Type OTHER

The device is hammock which look likes a rope

Standard Care 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.
3. 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sling-Swing Position

The device is hammock which look likes a rope

Intervention Type OTHER

Eligibility Criteria

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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

* Does not know Turkish language (reading-writing-speaking-listening)
* Pregnant women diagnosed with mental and/or auditory disabilities

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role collaborator

Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Nükhet Kaçar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara City Hospital- Maternity Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AnkaraCHBilkent-MH-NK

Identifier Type: -

Identifier Source: org_study_id