Pain ManagementNCT06898580
Sacral Massage With a Tennis Ball on Labor Pain and Comfort During the Intrapartum Period
A study testing sacral massage with tennis ball in people with Pain Management and Birth Comfort, run by Istanbul University - Cerrahpasa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Birth Comfort, Massage Effect
- What is being tested?
- sacral massage with tennis ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain Management, Birth Comfort, Massage Effect, Labor Pain
- Being tested
- sacral massage with tennis ball
- Keywords
- sacral massage, pain management, tennis ball, comfort of birth, reducing pain, labor pain
- Medical subject headings
- Agnosia, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacral massage with tennis ballOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Cervical dilatation will assses from 5-6 cm, 7-8 cm and 9-10 cm until delivery.
Secondary outcomes (1)
birth comfort
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.
Measured: Cervical dilatation will assses from 5-6 cm, 7-8 cm and 9-10 cm until delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with a experimental and control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, emine algül, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898580
- Sponsor's protocol ID
- IUC-EBE-EA-01
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sacral Massage With a Tennis Ball on Labor Pain and Comfort During the Intrapartum Period
- ClinicalTrials.gov ID
- NCT06898580
- Acronym / sponsor ID
- IUC-EBE-EA-01
- Conditions
- Pain Management, Birth Comfort, Massage Effect, Labor Pain
- Keywords
- sacral massage, pain management, tennis ball, comfort of birth, reducing pain, labor pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with a experimental and control
| Arm | Type | Receives |
|---|---|---|
| sacral massage with a tennis ball | Active comparator | Other: sacral massage with tennis ballWhen 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. |
| control groups | No intervention | –Pregnant women in the control group will not undergo any intervention other than routine hospital practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacral massage with tennis ballWhen 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. | Other | sacral massage with a tennis ball |
Primary outcome
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).
1 secondary outcome
birth comfort
Time frame: Cervical dilatation will assses from 5-6 cm, 7-8 cm and 9-10 cm until delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sacral massage with tennis ball in people with Pain Management and Birth Comfort, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor pain (time frame: Cervical dilatation will assses from 5-6 cm, 7-8 cm and 9-10 cm until delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.