NCT06927531 Effects of Pilates Ball and Sacral Massage Applications on Labor Pain, Labor Duration and Childbirth Satisfaction
| NCT ID | NCT06927531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ege University |
| Condition | Labor Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2025-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 105 participants in total. It began in 2025-02-20 with a primary completion date of 2025-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
As researchers, we believe that Pilates ball and manual sacral massage applications can be easily and cost-free applied in maternity clinics in our country. For all these reasons, this study was planned as a randomized controlled study to evaluate the effects of Pilates ball and sacral massage applications in labor on labor pain, labor duration, and labor satisfaction. The research will be carried out between December 1, 2024 and May 1, 2025 in two public hospitals affiliated with the Gaziantep Provincial Health Directorate. The sample of the research will consist of 35 pregnant women in the Pilates ball group, 35 in the sacral massage group and 35 in the control group, totaling 105 pregnant women who meet the criteria for inclusion in the research. Applications to the intervention groups will be made during the active phase of labor. Personal Information Form, Labor Monitoring Form, Application Monitoring Form to record the number and duration of applications, Visual Analog Scale to assess labor pain, Partograph to assess labor duration and Labor Satisfaction Scale to assess maternal satisfaction will be used in data collection. Data will be analyzed with tests appropriate to normal distribution characteristics in the SPSS 24 package program. At the end of the research, the effects of Pilates ball and sacral massage applications in labor on labor pain, labor duration and labor satisfaction will be evaluated.
Eligibility Criteria
Inclusion Criteria: * Pregnant women over 18 years old and under 35 years old * Term pregnancies (38-41 weeks gestation) * Primiparous * Those with a single live fetus * Vertex development * Those who do not have any risk factors during pregnancy (Dermatological disease, Preeclampsia, active membrane rupture, oligohydramnios and polyhydramnios, gestational diabetes, placental anomalies, intrauterine growth retardation, intrauterine dead fetus, macrosomic babies, fetal distress, etc.) * Those who do not have any obstacles for Pilates ball application * Those who do not have any chronic diseases (Hypertension, DM, ...) * Those in the active phase of labor, those who have at least 1 hour of labor follow-up * Pregnant women who voluntarily accept to participate in the study Exclusion Criteria: * Indications for Caesarean section (such as presentation disorder, breech presentation) * Those who underwent induction * Those whose labor duration was shorter than 1 hour or longer than 8 hours * Those who underwent vacuum forceps or shoulder insertion
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06927531 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 35 Years, studying Labor Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06927531 currently recruiting?
Yes, NCT06927531 is actively recruiting participants. Contact the research team at ebemisyen@hotmail.com for enrollment information.
Where is the NCT06927531 trial being conducted?
This trial is being conducted at Şehitkamil, Turkey (Türkiye).
Who is sponsoring the NCT06927531 clinical trial?
NCT06927531 is sponsored by Ege University. The trial plans to enroll 105 participants.