Labor PainNCT04827797
Effects of Different Birthing Balls Used at the First Stage of Childbirth
A study testing balls in people with Labor Pain and Satisfaction, Patient, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Satisfaction, Patient, Labor Fast
- What is being tested?
- balls
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 20 Dec 2019
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- primiparous
- admitted to the delivery room for vaginal delivery
- 38-40 week
- being in the latent phase of labor
- having no obstetric risks
Who cannot join
- undergo caesarean sections for various reasons
- having obstetric risks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Birthing Balls Used at the First Stage of Childbirth on Birth Outcomes and Maternal Satisfaction November, 2018
The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. The study included 3 groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially spherical birthing ball, were effective in reducing labor pain and facilitating faster rate of descent of the fetal head, and they increased maternal satisfaction.
Read the detailed description
The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. The study included 3 groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially spherical birthing ball, were effective in reducing labor pain and facilitating faster rate of descent of the fetal head, and they increased maternal satisfaction.
IMPACT STATEMENT What is already known on this subject? Labor pain and outcomes occurring during labor are known and expected situation. Some non-pharmacological methods are applied to ensure that birth is easy and maternal satisfaction is high.
What the results of this study add? There is no studies using the peanut ball and the spherical birth ball together. In our study, it was found that both balls are effective, but the spherical birth ball is more significant.
What the implications are of these findings for clinical practice and/or further research? Our study suggested that the spherical birth ball had effective on birth outcomes. Future studies should be performed to investigate the effects of birth balls in the postpartum period, breastfeeding or prenatal period.
- Conditions
- Labor Pain, Satisfaction, Patient, Labor Fast
- Being tested
- balls
- Keywords
- birth ball, labor pain, satisfaction, maternal, fetal
- Medical subject headings
- Labor Pain, Patient Satisfaction, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ballsDevice
Also called Birth ball, Peanut Ball
Birth balls to exercise
| Study group | Role | What they receive |
|---|---|---|
| birth ball | Experimental | The positions and movements for birth ball in the active and latent phases: kneeling on the ground and leaning on the spherical birthing ball, sitting on the ball with front support, sitting positions on the spherical birthing ball, full rotation of hip, moving to the right/left, back and forth. Positions and movements were repeated every 30 minutes. The 30-minute intervals were interrupted in cases where the women were not feeling well. Receives: Device: balls |
| peanut ball | Experimental | The positions and movements for the pregnant women in peanut ball: upright sitting position, forward bending positions, with backward and forward movement and swaying right and left on the peanut ball Receives: Device: balls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
this form consists of 7 questions regarding participants' descriptive and obstetric characteristics.
Measured: when pregnant women come to the delivery room
Visual Analogue Scale
in this scale, the participants marked the severity of their pain on a 10-cm ruler with one end stating "no pain" and the other end "worst possible pain". VAS was used to determine the severity of pain and the effectiveness of the intervention in this study.
Measured: Latent, active and transition phase in labor
Verbal Rating Scale
This scale is based on participants' choice of word that defines their pain state
Measured: Latent, active and transition phase of labor
Partogram
This is used starting from the active phase of labor. The progress of the labor and the health status of the baby are monitored on the partogram
Measured: active phase of labor
Evaluation Scale for Maternal Satisfaction with Normal Delivery
This is used to assess maternal satisfaction in normal delivery. Higher total scores on the scale indicate stronger maternal satisfaction with the hospital care provided in normal delivery
Measured: within a period of 1-4 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Nov 2018
- Primary completion30 Jul 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Sonmez, Gaziantep Islam Science and Technology University
- Investigators
- tuğçe sönmez, Principal investigator, Gaziantep ıslamic science and tecnology university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827797
- Sponsor's protocol ID
- 3301cukurova
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Birthing Balls Used at the First Stage of Childbirth on Birth Outcomes and Maternal Satisfaction November, 2018
- ClinicalTrials.gov ID
- NCT04827797
- Acronym / sponsor ID
- 3301cukurova
- Conditions
- Labor Pain, Satisfaction, Patient, Labor Fast
- Keywords
- birth ball, labor pain, satisfaction, maternal, fetal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 1 Apr 2021 (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.
The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. The study included 3 groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially spherical birthing ball, were effective in reducing labor pain and facilitating faster rate of descent of the fetal head, and they increased maternal satisfaction.
Detailed description
The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. The study included 3 groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially spherical birthing ball, were effective in reducing labor pain and facilitating faster rate of descent of the fetal head, and they increased maternal satisfaction.
IMPACT STATEMENT What is already known on this subject? Labor pain and outcomes occurring during labor are known and expected situation. Some non-pharmacological methods are applied to ensure that birth is easy and maternal satisfaction is high.
What the results of this study add? There is no studies using the peanut ball and the spherical birth ball together. In our study, it was found that both balls are effective, but the spherical birth ball is more significant.
What the implications are of these findings for clinical practice and/or further research? Our study suggested that the spherical birth ball had effective on birth outcomes. Future studies should be performed to investigate the effects of birth balls in the postpartum period, breastfeeding or prenatal period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| birth ball | Experimental | Device: ballsThe positions and movements for birth ball in the active and latent phases: kneeling on the ground and leaning on the spherical birthing ball, sitting on the ball with front support, sitting positions on the spherical birthing ball, full rotation of hip, moving to the right/left, back and forth. Positions and movements were repeated every 30 minutes. The 30-minute intervals were interrupted in cases where the women were not feeling well. |
| peanut ball | Experimental | Device: ballsThe positions and movements for the pregnant women in peanut ball: upright sitting position, forward bending positions, with backward and forward movement and swaying right and left on the peanut ball |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- primiparous
- admitted to the delivery room for vaginal delivery
- 38-40 week
- being in the latent phase of labor
- having no obstetric risks
Key exclusion criteria (2 listed)
- undergo caesarean sections for various reasons
- having obstetric risks
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 |
|---|---|---|
| ballsAlso: Birth ball, Peanut BallBirth balls to exercise | Device | birth ball, peanut ball |
Primary outcome
Introductory Information Form
Time frame: when pregnant women come to the delivery room
this form consists of 7 questions regarding participants' descriptive and obstetric characteristics.
Visual Analogue Scale
Time frame: Latent, active and transition phase in labor
in this scale, the participants marked the severity of their pain on a 10-cm ruler with one end stating "no pain" and the other end "worst possible pain". VAS was used to determine the severity of pain and the effectiveness of the intervention in this study.
Verbal Rating Scale
Time frame: Latent, active and transition phase of labor
This scale is based on participants' choice of word that defines their pain state
Partogram
Time frame: active phase of labor
This is used starting from the active phase of labor. The progress of the labor and the health status of the baby are monitored on the partogram
Evaluation Scale for Maternal Satisfaction with Normal Delivery
Time frame: within a period of 1-4 hours postpartum
This is used to assess maternal satisfaction in normal delivery. Higher total scores on the scale indicate stronger maternal satisfaction with the hospital care provided in normal delivery
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 1 Apr 2021.
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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.
tuğçe sönmez principal investigator
Gaziantep ıslamic science and tecnology 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 balls in people with Labor Pain and Satisfaction, Patient, run by Gaziantep Islam Science and Technology 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 5 inclusion and 2 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 1 Apr 2021. 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?
Introductory Information Form (time frame: when pregnant women come to the delivery room). The study lists 5 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 1 Apr 2021.