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RecruitingNCT06927531Updated Apr 15, 2025

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

An interventional study of sacral massage and pilates ball in Labor Pain and Satisfaction, sponsored by Ege University. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by Ege University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Feb 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Labor Pain
  • Satisfaction

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Keywords

  • sacral massage
  • pilates ball
03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's planned enrollment of 105 is close to the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    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: sacral massage

  • Experimental
    pilates ball

    During labor, pregnant women will be made to perform pelvic oscillation movements (full rotation of the hips, going right/left, coming forward and back, gently bouncing on a ball while holding on to the headboard) once an hour during the active phase of labor.

    Other: pilates ball

  • No intervention
    control

    Pregnant women in the control group will not be subjected to any intervention other than the routine practices of the clinic.

Interventions

  • Othersacral 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.

  • Otherpilates 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.

06

What researchers measure

Primary outcomes

  1. The intensity of pain will be measured with a visual pain scale.

    reduction in pain in intervention groups

    Time frame: prebirth during

07

Study locations

1 of 1 sites recruiting
  • Gaziantep Unıversity
    Şehi̇tkami̇l, Gazi̇antep, Turkey
    Recruiting
08

References and documents

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. PubMed 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. PubMed 39585392 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06927531
Lead sponsor
Ege University
Responsible party
emine can (res. asst., Ege University) — Principal investigator
First posted
Apr 15, 2025
Start date
Feb 20, 2025
Primary completion
May 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Apr 15, 2025

Study contacts

EMİNE CAN, ARAŞTIRMA GÖREVLİSİ
Contact
ebemisyen@hotmail.com
+905437371424

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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