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The Effect of Birth Ball Exercise on Labor Pain, Delivery Duration, Birth Comfort, and Birth Satisfaction (BB)

Primary Purpose

Childbirth Problems, Labor Pain, Birth Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
birth ball exercise
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Childbirth Problems focused on measuring Birth pain, labor duration, birth comfort, birth satisfaction, birth ball

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: being 18 years or older; being in 37-42 weeks of pregnancy; having a singleton pregnancy; having a cervical dilatation of 1-4 cm; being primiparous; not having any complications that prevent vaginal delivery; not having any extremity problems for using the birth ball and performing activities; being able to speak and understand Turkish. Exclusion criteria: Having maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature rupture of membranes, presentation anomalies, intrauterine growth retardation, fetal anomaly, intrauterine death, fetal macrosomia, fetal distress, etc.), getting pregnant by assisted reproductive techniques, electing cesarean section. Exclusion criteria in the research process: To receive induction (oxytocin, prostaglandins, and misoprostol); having a cesarean delivery due to any complications; the baby admitted to the neonatal intensive care unit for any reason; receiving analgesics.

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

No Intervention

Arm Description

Intervention Group Three different ball sizes, 55, 65 and 75 cm in diameter, were provided to the pregnant women, and the appropriate ball size was determined according to the height of the participant. In order for the pregnant woman to continue the balance exercises, they were allowed to sit on the round birth ball with their knees and hips at an angle of approximately 90°, with an upright spine. A birth ball of 55 cm was used for women between 150 and 160 cm in height, 65 cm for women between 160 and 170 cm, and 75 cm for women between 170 and 185 cm in height. Exercises with the round birth ball were guided by the researcher and the pregnant women performed the exercises in line with the guide. These are the movements performed with the round birth ball in 3 different positions: sitting (pelvic rocking movement, forward-backward and right-to-left rocking, forward supported sitting, and springing motion), kneeling, and squatting (ball hugging and pelvic rocking motion).

Control Group The followings were administered to the pregnant women in the Control Group after they were admitted to the hospital for delivery: Information was given about the research, Written consent was obtained, Routine practices and care were provided in the delivery room (taking anamnesis, taking vital signs, demonstrating correct breathing techniques, ensuring freedom of movement) Cervical changes were recorded on the partograph by vaginal examination, EFM (Electronic Fetal Monitoring) was applied based on doctor's orders, Fetal Heart Sound (FHS) was listened to every half hour and recorded on the partograph.

Outcomes

Primary Outcome Measures

Personal information form before intervention
Assessed using personal information. This instrument includes questions about women's sociodemographic, obstetric and childbirth readiness characteristics.
Evaluation of birth
Birth Follow-up Form was used to evaluate labor. This Birth Follow-up form is evaluating; partograph, effacement-dilatation at first admission to the hospital, presence of amniotic sac at first admission, presence of episiotomy, time from active phase of labor until dilation is complete, time until the baby's head comes out after full dilation.
Evaluation of labor pain
Pain of pregnant women during labor was evaluated with Visual Analogue Scale (VAS). VAS scale, which would be applied to evaluate episiotomy pain in the postpartum period, was used to convert some values that cannot be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line. The participant was asked to indicate where his or her condition is suitable on this line by drawing a line or by placing a dot or pointing. "No pain" is written on one end and "very severe pain" on the opposite end; the participant was asked to mark the pain condition on this line.was used to convert some values that could not be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line.
Evaluation of Childbirth Comfort Questionnaire
Childbirth Comfort Questionnaire (CCQ) scales were applied to measure their comfort at the time of birth. The scale determines the comfort levels of women during childbirth. The real name of the scale is "Childbirth Comfort Questionnaire". The original scale consists of 14 items and is in a five-point Likert type. Each item is scored between 1-5.
Birth results information
Birth results information form evaluates; APGAR score at the 1st, 5th, and 10th minutes of the newborn; baby's gender.
Evaluation of Childbirth Satisfaction
Mackey Childbirth Satisfaction Rating Scale (MCSRS) evaluation to determine birth satisfaction form has been applied. The scale assesses women's satisfaction with the birth process. The scale consists of six 34-item subscales (nine items about self-satisfaction, two items about spouse's satisfaction, three items about baby's satisfaction, nine items about midwife-nurse satisfaction, eight items about doctor's satisfaction, three items about labor pain and labor. satisfaction). The scale is 5-point Likert type and is scored between 1 and 5. The lowest score in the scale is 32 and the highest score is 169, and as the total score increases, birth satisfaction also increases.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2023
Last Updated
February 2, 2023
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05711472
Brief Title
The Effect of Birth Ball Exercise on Labor Pain, Delivery Duration, Birth Comfort, and Birth Satisfaction
Acronym
BB
Official Title
The Effect of Birth Ball Exercise on Labor Pain, Delivery Duration, Birth Comfort, and Birth Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
September 23, 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
It has been reported that the birth ball has benefits such as decreasing the perception of labor pain, reducing the anxiety level, shortening the duration of the first stage of labor, increasing the satisfaction of birth, and facilitating the descent of the fetal head, but the literature is quite limited. So, this randomized controlled experimental study aimed to examine the effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction.
Detailed Description
This randomized controlled experimental study aimed to examine the effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction. The sample of the study consisted of 120 primiparous pregnant women presented to the delivery room between November 2021 and April 2022. Pregnant women were randomly assigned to the Intervention Group (IG, n=60) or the Control Group (KG, n=60). After the cervical dilatation reached at 4 cm, the pregnant women in the IG performed birth ball exercises, adhering to the birth ball guide created by the researcher. No intervention was made in the control group other than standard midwifery care practices. A Personal Information Form,a Visual Analog Scale (VAS), the Childbirth Comfort Questionnaire (CCQ), a Labor and Postpartum Follow-up Form, and the Mackey Childbirth Satisfaction Rating Scale (MCSRS) were used for data collection. Women in both groups underwent VAS when cervical dilatation was 4 cm and 9 cm, and the CCQ was applied when dilatation was 8 cm. The MCSRS was administered two hours after delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childbirth Problems, Labor Pain, Birth Disorder
Keywords
Birth pain, labor duration, birth comfort, birth satisfaction, birth ball

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Intervention Group Three different ball sizes, 55, 65 and 75 cm in diameter, were provided to the pregnant women, and the appropriate ball size was determined according to the height of the participant. In order for the pregnant woman to continue the balance exercises, they were allowed to sit on the round birth ball with their knees and hips at an angle of approximately 90°, with an upright spine. A birth ball of 55 cm was used for women between 150 and 160 cm in height, 65 cm for women between 160 and 170 cm, and 75 cm for women between 170 and 185 cm in height. Exercises with the round birth ball were guided by the researcher and the pregnant women performed the exercises in line with the guide. These are the movements performed with the round birth ball in 3 different positions: sitting (pelvic rocking movement, forward-backward and right-to-left rocking, forward supported sitting, and springing motion), kneeling, and squatting (ball hugging and pelvic rocking motion).
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Control Group The followings were administered to the pregnant women in the Control Group after they were admitted to the hospital for delivery: Information was given about the research, Written consent was obtained, Routine practices and care were provided in the delivery room (taking anamnesis, taking vital signs, demonstrating correct breathing techniques, ensuring freedom of movement) Cervical changes were recorded on the partograph by vaginal examination, EFM (Electronic Fetal Monitoring) was applied based on doctor's orders, Fetal Heart Sound (FHS) was listened to every half hour and recorded on the partograph.
Intervention Type
Other
Intervention Name(s)
birth ball exercise
Intervention Description
birth ball exercise used in childbirth
Primary Outcome Measure Information:
Title
Personal information form before intervention
Description
Assessed using personal information. This instrument includes questions about women's sociodemographic, obstetric and childbirth readiness characteristics.
Time Frame
First 24 hours
Title
Evaluation of birth
Description
Birth Follow-up Form was used to evaluate labor. This Birth Follow-up form is evaluating; partograph, effacement-dilatation at first admission to the hospital, presence of amniotic sac at first admission, presence of episiotomy, time from active phase of labor until dilation is complete, time until the baby's head comes out after full dilation.
Time Frame
First 24 hours
Title
Evaluation of labor pain
Description
Pain of pregnant women during labor was evaluated with Visual Analogue Scale (VAS). VAS scale, which would be applied to evaluate episiotomy pain in the postpartum period, was used to convert some values that cannot be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line. The participant was asked to indicate where his or her condition is suitable on this line by drawing a line or by placing a dot or pointing. "No pain" is written on one end and "very severe pain" on the opposite end; the participant was asked to mark the pain condition on this line.was used to convert some values that could not be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line.
Time Frame
First 24 hours
Title
Evaluation of Childbirth Comfort Questionnaire
Description
Childbirth Comfort Questionnaire (CCQ) scales were applied to measure their comfort at the time of birth. The scale determines the comfort levels of women during childbirth. The real name of the scale is "Childbirth Comfort Questionnaire". The original scale consists of 14 items and is in a five-point Likert type. Each item is scored between 1-5.
Time Frame
First 24 hours
Title
Birth results information
Description
Birth results information form evaluates; APGAR score at the 1st, 5th, and 10th minutes of the newborn; baby's gender.
Time Frame
Postpartum 1sth hours (after birth first 1 hour)
Title
Evaluation of Childbirth Satisfaction
Description
Mackey Childbirth Satisfaction Rating Scale (MCSRS) evaluation to determine birth satisfaction form has been applied. The scale assesses women's satisfaction with the birth process. The scale consists of six 34-item subscales (nine items about self-satisfaction, two items about spouse's satisfaction, three items about baby's satisfaction, nine items about midwife-nurse satisfaction, eight items about doctor's satisfaction, three items about labor pain and labor. satisfaction). The scale is 5-point Likert type and is scored between 1 and 5. The lowest score in the scale is 32 and the highest score is 169, and as the total score increases, birth satisfaction also increases.
Time Frame
Postpartum 1sth hours (after birth first 1 hour)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: being 18 years or older; being in 37-42 weeks of pregnancy; having a singleton pregnancy; having a cervical dilatation of 1-4 cm; being primiparous; not having any complications that prevent vaginal delivery; not having any extremity problems for using the birth ball and performing activities; being able to speak and understand Turkish. Exclusion criteria: Having maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature rupture of membranes, presentation anomalies, intrauterine growth retardation, fetal anomaly, intrauterine death, fetal macrosomia, fetal distress, etc.), getting pregnant by assisted reproductive techniques, electing cesarean section. Exclusion criteria in the research process: To receive induction (oxytocin, prostaglandins, and misoprostol); having a cesarean delivery due to any complications; the baby admitted to the neonatal intensive care unit for any reason; receiving analgesics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
seyhan çankaya, PhD
Organizational Affiliation
Selcuk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University
City
Konya
ZIP/Postal Code
42050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Birth Ball Exercise on Labor Pain, Delivery Duration, Birth Comfort, and Birth Satisfaction

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