Back to resultsThe Effect of Using a Birth Ball and Squatting Position During Labor
Primary Purpose
Labor Pain, Labor Fast, Satisfaction, Patient
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Birth ball
Squatting
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain focused on measuring Labor Pain, Birth ball, Squatting, Duration of labor, Satisfaction
Eligibility Criteria
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
Sites / Locations
- Istanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Birth Ball Group
Squatting Group
Control Group
Arm Description
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.
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.
Usual routine care of the service.
Outcomes
Primary Outcome Measures
Personal and Obstetric Information Form
This form, prepared by the researcher, consists of 45 questions including sociodemographic, obstetric and obstetric follow-up information of women.
Visual Analog Scale (VAS)
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.
Partogram
It is a graphical form used to evaluate the progress of birth and the health status of the baby.
Evaluation Scale for Maternal Satisfaction with Normal Delivery
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05360823
Brief Title
The Effect of Using a Birth Ball and Squatting Position During Labor
Official Title
The Effect of Using a Birth Ball and Squatting Position During Labor on Labor Pain, Duration of Labor and Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 3, 2021 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
June 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fatma Dünmez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Labor Fast, Satisfaction, Patient
Keywords
Labor Pain, Birth ball, Squatting, Duration of labor, Satisfaction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Birth Ball Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Squatting Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual routine care of the service.
Intervention Type
Other
Intervention Name(s)
Birth ball
Intervention Description
Exercises for childbirth
Intervention Type
Other
Intervention Name(s)
Squatting
Intervention Description
Exercises for childbirth
Primary Outcome Measure Information:
Title
Personal and Obstetric Information Form
Description
This form, prepared by the researcher, consists of 45 questions including sociodemographic, obstetric and obstetric follow-up information of women.
Time Frame
pre-intervention
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
latent, active and transition phase of labor
Title
Partogram
Description
It is a graphical form used to evaluate the progress of birth and the health status of the baby.
Time Frame
active phase of labor
Title
Evaluation Scale for Maternal Satisfaction with Normal Delivery
Description
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.
Time Frame
Postpartum at the 4th hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Dünmez, Midwife
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
31060522
Citation
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.
Results Reference
background
PubMed Identifier
30080256
Citation
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.
Results Reference
background
PubMed Identifier
21546142
Citation
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.
Results Reference
background
Links:
URL
https://shgmkalitedb.saglik.gov.tr/Eklenti/6486/0/partografgenelgesipdf.pdf
Description
Ministry of Health Partograph Circular
Learn more about this trial
The Effect of Using a Birth Ball and Squatting Position During Labor
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