- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06898580
Sacral Massage With a Tennis Ball on Labor Pain and Comfort During the Intrapartum Period
The Effect of Sacral Massage With a Tennis Ball on Labor Pain and Comfort During the Intrapartum Period
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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