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

April 14, 2025 updated by: emine can, Ege University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Gazi̇antep
      • Şehi̇tkami̇l, Gazi̇antep, Turkey
        • Recruiting
        • Gaziantep Unıversity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.
No Intervention: control
Pregnant women in the control group will not be subjected to any intervention other than the routine practices of the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of pain will be measured with a visual pain scale.
Time Frame: prebirth during
reduction in pain in intervention groups
prebirth during

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Decision No: 24-9.1T/46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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