Sacral Massage With a Tennis Ball on Labor Pain and Comfort During the Intrapartum Period

May 10, 2025 updated by: emine algül, Istanbul University - Cerrahpasa

The Effect of Sacral Massage With a Tennis Ball on Labor Pain and Comfort During the Intrapartum Period

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.

Study Overview

Status

Not yet recruiting

Detailed Description

Pregnant women hospitalized in the maternity unit will be evaluated for compliance with the inclusion criteria. Women who meet the inclusion criteria and are willing to participate in the study will be randomized according to the simple random numbers table and the study group will be determined by the researcher by drawing lots. The purpose and stages of the study will be explained verbally to the women whose group is determined and the women will be asked to read and sign the Informed Voluntary Consent Form. Then, the Pregnancy Identification Form will be filled in by the researchers using the face-to-face interview method. Then the massage will be explained to the pregnant women in the experimental group and they will be asked to evaluate the Visual Analog Scale (VAS) before the procedure. While performing this application, the researcher will apply pressure to the sacral region with a tennis ball in a circular motion in a way 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 to mark the Birth Comfort Scale.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sacral massage with a tennis ball
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.
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.
No Intervention: control groups
Pregnant women in the control group will not undergo any intervention other than routine hospital practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labor pain
Time Frame: Cervical dilatation will assses from 5-6 cm, 7-8 cm and 9-10 cm until delivery.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
birth comfort
Time Frame: Cervical dilatation will assses from 5-6 cm, 7-8 cm and 9-10 cm until delivery.

Childbirth Comfort Questionnaire is a scale for assessing childbirth comfort. The validity and reliability of the scale was made by Potur et al. in 2014. The Scale maximum point is 45 and minumum point is nine. And as the scale score increases, the comfort level also increases.

When cervical dilatation is 5-6 cm, the pregnant woman is asked to check the appropriate options on the 9-item scale on the CCQ. We want this procedure to be done three times in total when the pregnant woman is 5-6 cm, 7-8 cm and 9-10 cm.

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

Collaborators and Investigators

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

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 (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUC-EBE-EA-01

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

product manufactured in and exported from the U.S.

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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