Childbirth ProblemsBBNCT05711472
The Effect of Birth Ball Exercise on Labor Pain, Delivery Duration, Birth Comfort, and Birth Satisfaction
A study testing birth ball exercise in people with Childbirth Problems and Labor Pain, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth Problems, Labor Pain, Birth Disorder
- What is being tested?
- birth ball exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Childbirth Problems, Labor Pain, Birth Disorder
- Being tested
- birth ball exercise
- Keywords
- Birth pain, labor duration, birth comfort, birth satisfaction, birth ball
- Medical subject headings
- Labor Pain, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
birth ball exerciseOther
birth ball exercise used in childbirth
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 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). Receives: Other: birth ball exercise |
| No Intervention | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal information form before intervention
Assessed using personal information. This instrument includes questions about women's sociodemographic, obstetric and childbirth readiness characteristics.
Measured: First 24 hours
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.
Measured: First 24 hours
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.
Measured: First 24 hours
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.
Measured: First 24 hours
Birth results information
Birth results information form evaluates; APGAR score at the 1st, 5th, and 10th minutes of the newborn; baby's gender.
Measured: Postpartum 1sth hours (after birth first 1 hour)
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.
Measured: Postpartum 1sth hours (after birth first 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Nov 2021
- Primary completion1 Apr 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth ProblemsStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhan Çankaya, Selcuk University
- Investigators
- seyhan çankaya, PhD, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711472
- Sponsor's protocol ID
- 2020/1924
- Acronym
- BB
- Status last verified
- Feb 2023
- First submitted
- 9 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Birth Ball Exercise on Labor Pain, Delivery Duration, Birth Comfort, and Birth Satisfaction
- ClinicalTrials.gov ID
- NCT05711472
- Acronym / sponsor ID
- BB / 2020/1924
- Conditions
- Childbirth Problems, Labor Pain, Birth Disorder
- Keywords
- Birth pain, labor duration, birth comfort, birth satisfaction, birth ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: birth ball exerciseIntervention 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). |
| No Intervention | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
- To receive induction (oxytocin, prostaglandins, and misoprostol);
- having a cesarean delivery due to any complications;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| birth ball exercisebirth ball exercise used in childbirth | Other | Experimental |
Primary outcome
Personal information form before intervention
Time frame: First 24 hours
Assessed using personal information. This instrument includes questions about women's sociodemographic, obstetric and childbirth readiness characteristics.
Evaluation of birth
Time frame: First 24 hours
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
Time frame: First 24 hours
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
Time frame: First 24 hours
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
Time frame: Postpartum 1sth hours (after birth first 1 hour)
Birth results information form evaluates; APGAR score at the 1st, 5th, and 10th minutes of the newborn; baby's gender.
Evaluation of Childbirth Satisfaction
Time frame: Postpartum 1sth hours (after birth first 1 hour)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
seyhan çankaya, PhD principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing birth ball exercise in people with Childbirth Problems and Labor Pain, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal information form before intervention (time frame: First 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.