NCT07165405

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

February 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

September 3, 2025

Last Update Submit

September 3, 2025

Conditions

Keywords

labor painbirth experiencepostpartum comfortsacral massageshower application

Outcome Measures

Primary Outcomes (1)

  • visual analog scale

    labour pain

    Before the shower and massage at 4-5 cm dilation, After the shower and massage at 4-5 cm dilation, Before the shower and massage at 6-8 cm dilation, After the shower and massage at 6-8 cm dilation. Control group: at 4-5 cm dilation and 6-8 cm dilation

Secondary Outcomes (2)

  • Childbirth Experience Questionnaire

    Before the transfer from the delivery room to the maternity ward after birth

  • Childbirth Comfort Questionnaire

    Before the transfer from the delivery room to the maternity ward after birth

Study Arms (3)

Showering with Partner Support

EXPERIMENTAL

Participants in this group will receive a shower administered by their partner on their back, abdomen, or entire body while standing or sitting, with the water temperature maintained between 32-37°C (the woman's preferred temperature will be applied) for at least 20 minutes upon admission to the labor room (when dilation is 4-5 cm). This will be performed under the observation of the researcher midwife. The application will be repeated when dilation reaches 7-8 cm.

Other: Shower

Hot Sacral Massage Group Made with Cherry Pits

EXPERIMENTAL

Sacral Massage Application will be performed using 20x20 cm pouches filled with cherry pits. Like the shower application, massage will be performed upon admission to the delivery room (when dilation is 4-5 cm) and repeated when dilation reaches 7-8 cm. Unless the pregnant woman requests otherwise, massage will be performed while she is in the left lateral position.

Other: Massage

Control Group

OTHER

Participants in this group will not receive any treatment beyond the routine hospital protocol (midwifery care).

Other: Midwifery Care

Interventions

ShowerOTHER

Participants in this group will receive a shower administered by their partner on their back, abdomen, or entire body while standing or sitting, with the water temperature maintained between 32-37°C (the woman's preferred temperature will be applied) for at least 20 minutes upon admission to the labor room (when dilation is 4-5 cm). This will be performed under the observation of the researcher midwife. The application will be repeated when dilation reaches 7-8 cm.

Showering with Partner Support
MassageOTHER

Sacral Massage Application will be performed using 20x20 cm pouches filled with cherry pits. Like the shower application, massage will be performed upon admission to the delivery room (when dilation is 4-5 cm) and repeated when dilation reaches 7-8 cm. Unless the pregnant woman requests otherwise, massage will be performed while she is in the left lateral position.

Hot Sacral Massage Group Made with Cherry Pits

Care provided by a midwife in the delivery room

Control Group

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:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Büyükçekmece, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainLabor Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Neriman Güdücü, PhD.

CONTACT

Buket Hasmili, Master Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

February 1, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations