NCT06898580

Brief Summary

Although pregnancy and labor are physiological events, the pain caused by uterine contractions during labor is among the most severe pains. This causes many women to fear labor. For this reason, control of labor pain should be one of the main goals of the care given to women in labor. Therefore, this study was designed to determine the effect of sacral massage with a tennis ball on labor pain and labor comfort in the intrapartum period.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 13, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 12, 2025

Last Update Submit

May 10, 2025

Conditions

Keywords

sacral massagepain managementtennis ballcomfort of birthreducing painlabor pain

Outcome Measures

Primary Outcomes (1)

  • Labor pain

    Visual Analog Scale (VAS) is a scale to measure pain and other subjective symptoms. It was as first introduced by Hayes and Patterson in 1921. The Scale maximum point is 10 and minimum point is zero. And as the scale score increases, the pain measure also increases.When cervical dilatation is 5-6 cm, the pregnant woman is asked to mark her pain score on a VAS (Visual Analog Scale) score from one to ten, and then massage is applied. After 30 minutes of massage, the pregnant woman is asked to rate the pain score on the VAS (Visual Analog Scale).

    Cervical dilatation will assses from 5-6 cm, 7-8 cm and 9-10 cm until delivery.

Secondary Outcomes (1)

  • birth comfort

    Cervical dilatation will assses from 5-6 cm, 7-8 cm and 9-10 cm until delivery.

Study Arms (2)

sacral massage with a tennis ball

ACTIVE COMPARATOR

When the cervical dilatation in labor is 5-6 cm, 7-8 cm and 9-10 cm, the woman will be asked to mark the intensity of the pain she feels on the VAS scale before starting the procedure. Then, the researcher explains sacral massage to the pregnant woman. While performing this application, the researcher will apply pressure to the sacral area with a tennis ball in a circular motion so that the patient can feel but not feel pain. The application will be applied to the pregnant woman for a total of 3 contractions. 30 minutes after each procedure, the woman will be asked again to mark the intensity of the pain she feels on the VAS scale and to mark the Birth Comfort Scale.

Other: sacral massage with tennis ball

control groups

NO INTERVENTION

Pregnant women in the control group will not undergo any intervention other than routine hospital practices.

Interventions

When the cervical dilatation in labor is 5-6 cm, 7-8 cm and 9-10 cm, the woman will be asked to mark the intensity of the pain she feels on the VAS scale before starting the procedure. Then, the researcher explains sacral massage to the pregnant woman. While performing this application, the researcher will apply pressure to the sacral area with a tennis ball in a circular motion so that the patient can feel but not feel pain. The application will be applied to the pregnant woman for a total of 3 contractions. 30 minutes after each procedure, the woman will be asked to mark the intensity of the pain she feels on the VAS scale and mark the Birth Comfort Scale. The research will end when a total of 70 experimental groups and 70 control groups are reached.

sacral massage with a tennis ball

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be able to read and write Turkish,
  • Being over 18 years old
  • Being primiparous
  • Singular foetus and head presentation
  • Pregnancy at term (37-42 weeks)
  • Those without risk factors during pregnancy
  • Being in the active phase of labour in stage 1
  • Women without any chronic diseases
  • Those without a diagnosed psychiatric illness
  • To agree to participate in the research

You may not qualify if:

  • If the participant wishes to leave the study voluntarily
  • Administration of any analgesic medication to reduce pain during labour
  • Development of any of the unexpected maternal-fetal risk conditions during labour
  • Having a caesarean section for any reason
  • The pregnant woman has spine and bone structure problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AgnosiaLabor Pain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups with a experimental and control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 27, 2025

Study Start

June 1, 2025

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

May 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share