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Recruiting NCT07165405

NCT07165405 Effects of Hot Sacral Massage and Shower Application With Partner Support on Labor

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Clinical Trial Summary
NCT ID NCT07165405
Status Recruiting
Phase
Sponsor Istanbul University - Cerrahpasa
Condition Pain
Study Type INTERVENTIONAL
Enrollment 150 participants
Start Date 2025-02-01
Primary Completion 2025-09-30

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
ShowerMassageMidwifery Care

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 150 participants in total. It began in 2025-02-01 with a primary completion date of 2025-09-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This study was designed to determine the effect of warm sacral massage with cherry pits and showering with partner support on perceived labor pain, birth experience, and birth comfort. A total of 150 pregnant women, 50 in each group, were planned to be included in the study. Volunteers who agreed to participate in the study were expected to have spontaneous vaginal delivery, with an ultrasound-estimated fetal weight between 2500-4000 grams, a single fetus in cephalic presentation, at term (between 37-42 weeks of gestation), in the active phase of labor (4 cm cervical dilation), primiparous women who did not receive analgesia or anesthesia during the first stage of labor and who did not have any skin disease or open wound that would prevent massage or showering. Pregnant women participating in the study will be randomly divided into three groups. The massage group will receive massage twice during the first stage of labor for at least 20 minutes, either standing or sitting, using a bag filled with cherry pits on the sacral region (the lumbar region including your tailbone). Pregnant women in the shower group will receive a shower with water at a temperature between 32-37°C for at least 20 minutes twice during the first stage of labor, either standing or sitting with partner support, according to their preference. Pregnant women in the control group will not receive any intervention other than the routine hospital protocol (midwifery care). After providing information about the study to the pregnant women, written informed consent will be obtained. The pain scale (VAS) will be administered to women in the shower group, massage group, and control group by a midwife working in the delivery room who is not involved in the study. The VAS will be administered four times during labor to pregnant women in the massage group and shower group, and four times to pregnant women in the control group. Before transfer to the ward after delivery, all participants in the groups will be administered the "Birth Experience Scale (BES) and Birth Comfort Scale (BCS)" by a midwife who is not involved in the study and is working in the delivery room that day.

Eligibility Criteria

Inclusion Criteria: * Volunteering to participate in the study * Expectation of spontaneous vaginal delivery * Estimated fetal weight between 2500-4000 grams by ultrasound * Single fetus and cephalic presentation, * Term pregnancy (between 37-42 weeks of gestation) * Being in the active phase of labor (cervical dilation of 4 cm) * No analgesia or anesthesia used during the first stage of labor, * No skin disease or open wound preventing massage or showering Exclusion Criteria: * Having undergone infertility treatment, * Delivery by cesarean section for any reason during labor, * Being multiparous * Having any systemic, chronic, or neurological disease (Diabetes Mellitus, Hypertension, Thyroid disorders, Multiple Sclerosis, Epilepsy, etc.) * Regular medication use due to any illness, * Active psychiatric treatment (pharmacotherapy/psychotherapy), * Any induction that may affect uterine contractions and dilation, * Any pregnancy complications (such as placenta previa, preeclampsia, premature rupture of membranes, oligohydramnios, and polyhydramnios) * Interventional delivery (forceps, vacuum) * Any problem that hinders communication (such as not knowing Turkish, hearing, speech, and comprehension disorders)

Contact & Investigator

Central Contact

Neriman Güdücü, PhD.

✉ nerimanteker@windowslive.com

📞 +905548327328

Frequently Asked Questions

Who can join the NCT07165405 clinical trial?

This trial is open to female participants only, aged 18 Years or older, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07165405 currently recruiting?

Yes, NCT07165405 is actively recruiting participants. Contact the research team at nerimanteker@windowslive.com for enrollment information.

Where is the NCT07165405 trial being conducted?

This trial is being conducted at Istanbul, Turkey (Türkiye).

Who is sponsoring the NCT07165405 clinical trial?

NCT07165405 is sponsored by Istanbul University - Cerrahpasa. The trial plans to enroll 150 participants.

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