- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05360823
The Effect of Using a Birth Ball and Squatting Position During Labor
July 26, 2022 updated by: Fatma Dünmez
The Effect of Using a Birth Ball and Squatting Position During Labor on Labor Pain, Duration of Labor and Satisfaction
The aim of the study was to evaluate the effect of using the birth ball and squatting position during labor on labor pain, duration of labor and satisfaction.
The research is a randomized controlled experimental study.
The sample of the study consisted of a total of 159 pregnant women, 53 in the birthing ball application group, 53 in the squatting group, and 53 in the control group, who met the criteria for inclusion in the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
159
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Istanbul, Turkey
- Istanbul University-Cerrahpasa
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- No risky pregnancy
- Gestational week between 37-42
- Unopened amniotic membrane
- Those who will give birth vaginally
- In active phase
- Fluent in Turkish
- Singleton pregnancy
- Primiparous
Exclusion Criteria:
- Any complication development
- Cesarean section status
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Birth Ball Group
In the active and transitional phases, during contractions, performing exercises on the birth ball (fully rotating the hip, moving to the right/left, coming back and forth, and slightly bouncing while sitting on the birth ball) (average 25 minutes).
In order to monitor the condition of the fetus, exercises on the birth ball were performed by the pregnant woman during contractions while connected to NST.
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Exercises for childbirth
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Experimental: Squatting Group
In the active and transitional phase, squatting position (squatting with feet shoulder-width apart by laying a clean sheet on the floor and getting support from a bed, chair or birth ball) during contractions (average 25 minutes).
In order to monitor the condition of the fetus, the squatting position was used by the pregnant woman during contractions while connected to the NST.
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Exercises for childbirth
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No Intervention: Control Group
Usual routine care of the service.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personal and Obstetric Information Form
Time Frame: pre-intervention
|
This form, prepared by the researcher, consists of 45 questions including sociodemographic, obstetric and obstetric follow-up information of women.
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pre-intervention
|
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Visual Analog Scale (VAS)
Time Frame: latent, active and transition phase of labor
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It is a measuring instrument with a score between 0 (no pain) and 10 (severe pain), divided equally by marks on a horizontal or vertical 10 cm line.
Horizontal form was used in the research.
The scale was used to assess the severity of pain.
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latent, active and transition phase of labor
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Partogram
Time Frame: active phase of labor
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It is a graphical form used to evaluate the progress of birth and the health status of the baby.
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active phase of labor
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Evaluation Scale for Maternal Satisfaction with Normal Delivery
Time Frame: Postpartum at the 4th hour
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This is used to assess the mother's level of satisfaction at birth.
The scale, which has a validity and reliability of 0.91 in Turkey, was developed by Güngör and Beji in 2009.
It is a 5-point Likert-type scale consisting of 43 items and 10 sub-dimensions.
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Postpartum at the 4th hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fatma Dünmez, Midwife, Istanbul University - Cerrahpasa (IUC)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gungor I, Beji NK. Development and psychometric testing of the scales for measuring maternal satisfaction in normal and caesarean birth. Midwifery. 2012 Jun;28(3):348-57. doi: 10.1016/j.midw.2011.03.009. Epub 2011 May 4.
- Lavender T, Cuthbert A, Smyth RM. Effect of partograph use on outcomes for women in spontaneous labour at term and their babies. Cochrane Database Syst Rev. 2018 Aug 6;8(8):CD005461. doi: 10.1002/14651858.CD005461.pub5.
- Yeung MPS, Tsang KWK, Yip BHK, Tam WH, Ip WY, Hau FWL, Wong MKW, Ng JWY, Liu SH, Chan SSW, Law CK, Wong SYS. Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trial. BMC Pregnancy Childbirth. 2019 May 6;19(1):153. doi: 10.1186/s12884-019-2305-8.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2021
Primary Completion (Actual)
January 20, 2022
Study Completion (Actual)
June 24, 2022
Study Registration Dates
First Submitted
April 26, 2022
First Submitted That Met QC Criteria
April 30, 2022
First Posted (Actual)
May 4, 2022
Study Record Updates
Last Update Posted (Actual)
July 28, 2022
Last Update Submitted That Met QC Criteria
July 26, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISBASP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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