Back to resultsEffect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor
Primary Purpose
Pain, Labor Pain, Satisfaction
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Birth Ball
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring Birth ball, birth satisfaction, pain, midwifery care
Eligibility Criteria
Inclusion Criteria:
- the consent of the pregnant women to participate in the study,
- have signed the informed consent form,
- be over the age of 18,
- Vaginal opening was determined as 4 cm
Exclusion Criteria:
- Having a psychologically diagnosed disorder
- Pregnant women diagnosed with risky pregnancy
Sites / Locations
- Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: Birth Ball
Control
Arm Description
In the second stage, the birth ball application was made and followed. Pregnant women with a vaginal opening of 4 cm admitted to the delivery room were instructed to sit on the delivery ball for a total of 30 minutes. A stopwatch clock was used to determine these 30 minutes. The pregnant woman was not asked to sit on the ball all the time, and she could take a break for rest or other needs. The birth ball, which is suitable for women's use, was preferred in 45 cm dimensions, and the pilates circle was used as a stabilizer. Under the supervision of the researcher, the pregnant women sat upright on the ball and began to rock back and forth. Meanwhile, the researcher held the pregnant woman's hand. In order for the pregnant woman not to lose her balance, the birth ball was placed on a pilates circle and she was supported by the researcher in making the movements.
A routine care was performed.
Outcomes
Primary Outcome Measures
Introductory Information Form
The form consisting of 13 questions was prepared by the researcher in order to describe the sociodemographic characteristics and current health status of women.
Birth Process Follow-up Form
It was created by the researcher in order to obtain information about the progress of birth and the characteristics of the fetus during the birth process of the pregnant. In the form, there are questions including the hour and subsequent follow-up hours when the vaginal opening is 4 cm, dilatation, fetal heartbeat, whether there is oxytocin administration, the duration and frequency of contractions, and the characteristics of the amniotic fluid.
Secondary Outcome Measures
Visual Analog Scale (VAS)
It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). A 10 cm vertical form was used in the study. Pain level was evaluated with VAS during each follow-up of the pregnant woman.
Birth Satisfaction Scale-Short Form (DME-F)
The short form of the scale was revised by Martin et al. in 2016 to evaluate the birth satisfaction levels of women (Martin et al., 2016). The Turkish validity and reliability study was conducted by Serhatlıoğlu et al. in 2018 (Göncü Serhatlıoğlu et al., 2018). The scale consists of 10 items and a minimum of 0 and a maximum of 40 points can be obtained. The items of the scale are in a 5-point Likert type and are scored as Strongly agree (4 points)-Strongly Disagree (0 points).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05312502
Brief Title
Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor
Official Title
Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
H0: There is no difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during labor.
H1: There is a difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during the birth process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Labor Pain, Satisfaction
Keywords
Birth ball, birth satisfaction, pain, midwifery care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The sample size was 106 pregnant women, 53 in each group, with a known score using the G*Power 3.1.7 program (intervention group=29.19±5.86-control group=26.51±5.13) with 85% power, 0.48 effect size and 0.15 error. was calculated as. Considering data loss, it is planned to reach 10% more pregnant women. Intervention group=57, control group=54 pregnants, and the study was terminated. The women were divided into two groups using the random numbers table in the simple random sampling method. Single blinding was performed on the women participating in the study. However, in order to prevent bias, the researcher who collected the data gave codes to the questionnaire forms of the pregnant women.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Birth Ball
Arm Type
Experimental
Arm Description
In the second stage, the birth ball application was made and followed. Pregnant women with a vaginal opening of 4 cm admitted to the delivery room were instructed to sit on the delivery ball for a total of 30 minutes. A stopwatch clock was used to determine these 30 minutes. The pregnant woman was not asked to sit on the ball all the time, and she could take a break for rest or other needs. The birth ball, which is suitable for women's use, was preferred in 45 cm dimensions, and the pilates circle was used as a stabilizer. Under the supervision of the researcher, the pregnant women sat upright on the ball and began to rock back and forth. Meanwhile, the researcher held the pregnant woman's hand. In order for the pregnant woman not to lose her balance, the birth ball was placed on a pilates circle and she was supported by the researcher in making the movements.
Arm Title
Control
Arm Type
No Intervention
Arm Description
A routine care was performed.
Intervention Type
Other
Intervention Name(s)
Birth Ball
Intervention Description
During labour, the pregnant woman was positioned using a birth ball.
Primary Outcome Measure Information:
Title
Introductory Information Form
Description
The form consisting of 13 questions was prepared by the researcher in order to describe the sociodemographic characteristics and current health status of women.
Time Frame
pre-intervention
Title
Birth Process Follow-up Form
Description
It was created by the researcher in order to obtain information about the progress of birth and the characteristics of the fetus during the birth process of the pregnant. In the form, there are questions including the hour and subsequent follow-up hours when the vaginal opening is 4 cm, dilatation, fetal heartbeat, whether there is oxytocin administration, the duration and frequency of contractions, and the characteristics of the amniotic fluid.
Time Frame
during the intervention
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). A 10 cm vertical form was used in the study. Pain level was evaluated with VAS during each follow-up of the pregnant woman.
Time Frame
during the intervention
Title
Birth Satisfaction Scale-Short Form (DME-F)
Description
The short form of the scale was revised by Martin et al. in 2016 to evaluate the birth satisfaction levels of women (Martin et al., 2016). The Turkish validity and reliability study was conducted by Serhatlıoğlu et al. in 2018 (Göncü Serhatlıoğlu et al., 2018). The scale consists of 10 items and a minimum of 0 and a maximum of 40 points can be obtained. The items of the scale are in a 5-point Likert type and are scored as Strongly agree (4 points)-Strongly Disagree (0 points).
Time Frame
in the first hour in postpartum period
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
the consent of the pregnant women to participate in the study,
have signed the informed consent form,
be over the age of 18,
Vaginal opening was determined as 4 cm
Exclusion Criteria:
Having a psychologically diagnosed disorder
Pregnant women diagnosed with risky pregnancy
Facility Information:
Facility Name
Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital
City
Konya
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor
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