NCT06927531

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 15, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 20, 2025

Last Update Submit

April 14, 2025

Conditions

Keywords

sacral massagepilates ball

Outcome Measures

Primary Outcomes (1)

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

    reduction in pain in intervention groups

    prebirth during

Study Arms (3)

sacral massage

EXPERIMENTAL

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

pilates ball

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

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.

sacral massage

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.

pilates ball

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Unıversity

Şehitkamil, Gazi̇antep, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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: 39673988BACKGROUND
  • https://doi.org/10.1111/jjns.12580

    BACKGROUND
  • 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: 39585392BACKGROUND

MeSH Terms

Conditions

Labor PainPersonal Satisfaction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

EMİNE CAN, ARAŞTIRMA GÖREVLİSİ

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
res. asst.

Study Record Dates

First Submitted

February 20, 2025

First Posted

April 15, 2025

Study Start

February 20, 2025

Primary Completion

May 30, 2025

Study Completion

December 30, 2025

Last Updated

April 15, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations