NCT07151144

Brief Summary

Study Design This study is a quasi-experimental research designed to examine the effects of massage and warm shower-used as non-pharmacological methods during labor-on birth satisfaction, maternal comfort, and breastfeeding success. tudy Population The study was conducted in the delivery unit of a public hospital in Turkey in 2025. The sample consisted of women who were experiencing their first pregnancy and giving birth for the first time. Inclusion criteria were as follows: Between 37 and 42 weeks of gestation, Low-risk, singleton pregnancies, Planned for vaginal delivery, No significant obstetric complications during pregnancy, Voluntarily agreed to participate in the study. A total of 120 participants were randomly assigned into three groups: Massage Group (n=430): Received massage during labor. Shower Group (n=40): Took a warm shower during labor. Control Group (n=40): Received routine standard hospital care without any additional intervention. Data Collection Tools Data were collected using the following instruments: Personal Information Form Birth Satisfaction Scale Birth Comfort Scale Breastfeeding Success Scale Intervention Massage Group: During the active phase of labor (cervical dilation of 4-7 cm), participants received 15-minute sessions of light-pressure massage to the lower back, sacrum, and lumbar area at regular intervals. Shower Group: During the same phase, participants were assisted to take a warm shower for approximately 20 minutes. Control Group: Received routine intrapartum care with no additional non-pharmacological intervention

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 18, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

July 18, 2025

Last Update Submit

December 28, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Birth Satisfaction

    Evaluated using the Birth Satisfaction Scale (BSS), which measures a mother's satisfaction with her labor and delivery experience (The scale is a 30-item Likert-type scale. The lowest possible score is 30, and the highest is 150. A higher score indicates higher birth satisfaction.). The scale includes multiple dimensions such as quality of care, personal attributes, and stress experienced during labor. 25 September, 2025-15 December, 2025

    up to 3 months

  • Maternal Comfort

    Maternal Comfort: Assessed through the Birth Comfort Scale, which evaluates physical, emotional, and environmental aspects of comfort experienced by the mother during labor (The scale is a 34-item Likert-type scale. The lowest possible score is 34, and the highest is 170. A higher score indicates higher postpartum comfort). 25 September, 2025-15 December, 2025

    up to 3 months

  • Breastfeeding Success:

    Measured within the first hours postpartum using the LATCH Breastfeeding Assessment Tool, which assesses five components: Latch, Audible swallowing, Type of nipple, Comfort (breast/nipple), and Hold (positioning).A low score indicates unsuccessful breastfeeding, while a high score indicates successful breastfeeding.

    Within the first 2 hours postpartum

Study Arms (2)

intervention group

EXPERIMENTAL

Massage and Showe

Other: MassageOther: Shower

Control group

NO INTERVENTION

Control group

Interventions

MassageOTHER

During the active phase of labor (cervical dilation of 4-7 cm), participants received 15-minute sessions of light-pressure massage to the lower back, sacrum, and lumbar area at regular intervals.

intervention group
ShowerOTHER

During the same phase, participants were assisted to take a warm shower for approximately 20 minutes.

intervention group

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 37 and 42 weeks of gestation,
  • Low-risk, singleton pregnancies,
  • Planned for vaginal delivery,
  • No significant obstetric complications during pregnancy,
  • Voluntarily agreed to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 18, 2025

First Posted

September 3, 2025

Study Start

August 25, 2025

Primary Completion

November 15, 2025

Study Completion

December 15, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons.

Locations