Labor PainNCT05360823
The Effect of Using a Birth Ball and Squatting Position During Labor
A study testing Birth ball and Squatting in people with Labor Pain and Labor Fast, run by Fatma Dünmez at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Labor Fast, Satisfaction, Patient
- What is being tested?
- Birth ball and Squatting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2021to 24 Jun 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Any complication development
- Cesarean section status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using a Birth Ball and Squatting Position During Labor on Labor Pain, Duration of Labor and Satisfaction
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.
- Conditions
- Labor Pain, Labor Fast, Satisfaction, Patient
- Being tested
- Birth ball, Squatting
- Keywords
- Labor Pain, Birth ball, Squatting, Duration of labor, Satisfaction
- 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.
Birth ballOther
Exercises for childbirth
SquattingOther
Exercises for childbirth
| Study group | Role | What they receive |
|---|---|---|
| Birth Ball Group | Experimental | 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. Receives: Other: Birth ball |
| Squatting Group | Experimental | 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. Receives: Other: Squatting |
| Control Group | No intervention | Usual routine care of the service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-intervention
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.
Measured: latent, active and transition phase of labor
Partogram
It is a graphical form used to evaluate the progress of birth and the health status of the baby.
Measured: active phase of labor
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.
Measured: Postpartum at the 4th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start3 Jul 2021
- Primary completion20 Jan 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatma Dünmez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma Dünmez, Istanbul University - Cerrahpasa
- Investigators
- Fatma Dünmez, Midwife, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360823
- Sponsor's protocol ID
- ISBASP
- Status last verified
- Jul 2022
- First submitted
- 26 Apr 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31060522Lavender 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.
PubMed 30080256Gungor 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.
PubMed 21546142Dunmez F, Yilmaz T. The effect of using birth ball and squatting position during labor on pain, duration, and satisfaction: A randomized controlled trial. Jpn J Nurs Sci. 2024 Apr;21(2):e12580. doi: 10.1111/jjns.12580. Epub 2023 Dec 10.
PubMed 38073180
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using a Birth Ball and Squatting Position During Labor on Labor Pain, Duration of Labor and Satisfaction
- ClinicalTrials.gov ID
- NCT05360823
- Acronym / sponsor ID
- ISBASP
- Conditions
- Labor Pain, Labor Fast, Satisfaction, Patient
- Keywords
- Labor Pain, Birth ball, Squatting, Duration of labor, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Fatma DünmezUniversity, hospital or other
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 4 May 2022 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Birth Ball Group | Experimental | Other: Birth ballIn 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. |
| Squatting Group | Experimental | Other: SquattingIn 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. |
| Control Group | No intervention | –Usual routine care of the service. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- No risky pregnancy
- Gestational week between 37-42
- Unopened amniotic membrane
- Those who will give birth vaginally
- In active phase
Key exclusion criteria (2 listed)
- Any complication development
- Cesarean section status
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 ballExercises for childbirth | Other | Birth Ball Group |
| SquattingExercises for childbirth | Other | Squatting Group |
Primary outcome
Personal and Obstetric Information Form
Time frame: pre-intervention
This form, prepared by the researcher, consists of 45 questions including sociodemographic, obstetric and obstetric follow-up information of women.
Visual Analog Scale (VAS)
Time frame: latent, active and transition phase of labor
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
Time frame: active phase of labor
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
Time frame: Postpartum at the 4th hour
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.
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 28 Jul 2022.
- Background: PubMed 31060522Yeung 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.
- Background: PubMed 30080256Lavender 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.
- Background: PubMed 21546142Gungor 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.
- Derived from this study: PubMed 38073180Dunmez F, Yilmaz T. The effect of using birth ball and squatting position during labor on pain, duration, and satisfaction: A randomized controlled trial. Jpn J Nurs Sci. 2024 Apr;21(2):e12580. doi: 10.1111/jjns.12580. Epub 2023 Dec 10.
- Ministry of Health Partograph CircularLink provided by the sponsor.
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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.
Fatma Dünmez, Midwife principal investigator
Istanbul University - Cerrahpasa
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 and Squatting in people with Labor Pain and Labor Fast, run by Fatma Dünmez 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 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 28 Jul 2022. 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 and Obstetric Information Form (time frame: pre-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05360823, which also lists 4 linked publications.
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 28 Jul 2022.