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Recruiting NCT06927531

Effects of Pilates Ball and Sacral Massage Applications on Labor Pain, Labor Duration and Childbirth Satisfaction

No phase Interventional Labor Pain Satisfaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sacral massage, pilates ball.
Who it may be relevant to
Registry conditions: Labor Pain, Satisfaction. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Pilates Ball and Sacral Massage Applications on Labor Pain, Labor Duration and Childbirth Satisfaction: A Randomized Controlled Study

Overview

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.

Detailed description

Childbirth is one of the most special processes experienced in women's lives, significantly affecting their quality of life. Pain and fear experienced during the birth process are associated with many negative outcomes affecting the woman and the fetus/newborn, such as decreased childbirth satisfaction, preference for cesarean section, prolonged and difficult labor, and postpartum depression. Non-pharmacological methods that can be used to cope with labor pain are comfortable, safe, easy-to-use, and low-cost non-invasive methods that midwives can perform independently and in collaboration with the pregnant woman. Midwives working in delivery rooms should be able to apply non-pharmacological methods to cope with labor pain and should help teach and implement these methods by knowing their limitations and effects.

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.

Interventions

  • Other sacral massage
    During labor, pregnant women will be given effleurage (stroking) and vibration (vibration) techniques to the sacral region in a comfortable position during contractions, once an hour for a maximum of 10 minutes.
  • Other pilates ball
    During labor, pregnant women will be given pelvic oscillation movements (a full rotation of the hips, going right/left, coming forward and backward, lightly bouncing on a ball while holding onto the headboard) once an hour during the active phase of labor.

Primary outcome measures

  • The intensity of pain will be measured with a visual pain scale. [Time frame: prebirth during]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Gaziantep Unıversity — Şehitkamil

Publications

  • Makvandi S, Hadizadeh-Talasaz Z, Nosrati Hadi Abad SF, Manouchehri E, Larki M. Effectiveness of sacral massage during labor in pregnant women: A systematic review and meta-analysis. Midwifery. 2025 Feb;141:104252. doi: 10.1016/j.midw.2024.104252. Epub 2024 Nov 28. PMID 39673988
  • https://doi.org/10.1111/jjns.12580
  • Erkal Aksoy Y, Dereli Yilmaz S, Celimli S. Effect of using a birth ball on birth satisfaction and pain in pregnant women during labor: a randomized controlled trial. Arch Gynecol Obstet. 2024 Dec;310(6):2999-3007. doi: 10.1007/s00404-024-07825-3. Epub 2024 Nov 25. PMID 39585392

Identifiers

NCT: NCT06927531 · Decision No: 24-9.1T/46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗