PainNCT05312502
Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor
A study testing Birth Ball in people with Pain and Labor Pain, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Labor Pain, Satisfaction
- What is being tested?
- Birth Ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 Dec 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 19 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Having a psychologically diagnosed disorder
- Pregnant women diagnosed with risky pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital
Konya
About this study
Official title: Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor: A Randomized Controlled Trial
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.
- Conditions
- Pain, Labor Pain, Satisfaction
- Being tested
- Birth Ball
- Keywords
- Birth ball, birth satisfaction, pain, midwifery care
- Medical subject headings
- Pain, Labor Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth BallOther
During labour, the pregnant woman was positioned using a birth ball.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Birth Ball | Experimental | 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. Receives: Other: Birth Ball |
| Control | No intervention | A routine care was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-intervention
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.
Measured: during the intervention
Secondary outcomes (2)
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.
Measured: during the intervention
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).
Measured: in the first hour in postpartum period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Mar 2020
- Primary completion1 Jun 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin ERKAL AKSOY, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312502
- Sponsor's protocol ID
- 0000-0002
- Status last verified
- May 2023
- First submitted
- 21 Mar 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kilic S, Dereli Yilmaz S. Virtual Reality Headset Simulating a Nature Environment to Improve Health Outcomes in Pregnant Women: A Randomized-Controlled Trial. Clin Nurs Res. 2023 Nov;32(8):1104-1114. doi: 10.1177/10547738231184923. Epub 2023 Jul 5.
PubMed 37408298
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05312502
- Acronym / sponsor ID
- 0000-0002
- Conditions
- Pain, Labor Pain, Satisfaction
- Keywords
- Birth ball, birth satisfaction, pain, midwifery care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 5 Apr 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Birth Ball | Experimental | Other: Birth BallIn 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. |
| Control | No intervention | –A routine care was performed. |
Who may qualify
- Ages
- 19 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Having a psychologically diagnosed disorder
- Pregnant women diagnosed with risky pregnancy
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 BallDuring labour, the pregnant woman was positioned using a birth ball. | Other | Experimental: Birth Ball |
Primary outcome
Introductory Information Form
Time frame: pre-intervention
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
Time frame: during the intervention
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.
2 secondary outcomes
Visual Analog Scale (VAS)
Time frame: during the intervention
Birth Satisfaction Scale-Short Form (DME-F)
Time frame: in the first hour in postpartum period
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 25 May 2023.
- Derived from this study: PubMed 37408298Kilic S, Dereli Yilmaz S. Virtual Reality Headset Simulating a Nature Environment to Improve Health Outcomes in Pregnant Women: A Randomized-Controlled Trial. Clin Nurs Res. 2023 Nov;32(8):1104-1114. doi: 10.1177/10547738231184923. Epub 2023 Jul 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Pain 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 4 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 25 May 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?
Introductory Information Form (time frame: pre-intervention). The study lists 2 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 NCT05312502, which also lists 1 linked publication.
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 25 May 2023.