NCT07304804

Brief Summary

The goal of this clinical trial was to learn whether baby massage training could improve midwifery students' knowledge about baby massage. The study focused on students in their third and fourth years who had already completed child health and neonatal care courses. The main question was whether students who received baby massage training would have higher knowledge scores after the training compared with students who did not receive the training. Researchers randomly assigned 64 midwifery students into two groups: Training group (32 students): received structured baby massage education that included a video demonstration, mannequin practice, and guided feedback. Control group (32 students): did not receive any baby massage training during the study period. Each student completed a questionnaire about baby massage before and after the training. The questionnaire contained 15 yes/no questions about preparation, application, and post-application steps of infant massage. Training sessions lasted 30 to 45 minutes and were delivered by an experienced instructor in a classroom environment. The intervention took place in April-May 2024 at Atatürk University, Faculty of Health Sciences, in Türkiye. After the training, students in the training group had significantly higher knowledge scores than those in the control group. The results showed that structured baby massage education increased the students' knowledge and awareness of infant massage practices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

December 12, 2025

Last Update Submit

December 12, 2025

Conditions

Keywords

Baby massageMidwifery educationKnowledge levelRandomized controlled trialInfant careSimulation-based training

Outcome Measures

Primary Outcomes (1)

  • Infant Massage Knowledge Score

    Change in participants' knowledge about infant massage before and after the educational intervention. Knowledge is assessed using the Infant Massage Knowledge Questionnaire (Gürol, 2010), which includes 15 yes/no items divided into three subscales: preparation, application, and post-application phases.

    Measured before training (pre-test) and after training (post-test, immediately after intervention)

Secondary Outcomes (1)

  • Knowledge Retention Score

    1 month after the intervention (if follow-up conducted).

Study Arms (2)

Baby Massage Training

EXPERIMENTAL

Participants in this group received baby massage training, which included three 30-45 minute sessions consisting of a baby massage video, mannequin-based demonstration, and guided practice. The sessions aimed to improve students' knowledge and understanding of baby massage techniques.

Behavioral: Baby Massage Training

Control: No Training

NO INTERVENTION

Participants in this group did not receive any baby massage training. They completed the same pre-test and post-test assessments as the experimental group to evaluate changes in knowledge levels without exposure to the intervention.

Interventions

A structured educational intervention consisting of three sessions (30-45 minutes each). The training included video presentation, mannequin demonstration, and guided practice on baby massage techniques.

Also known as: Baby Massage Education
Baby Massage Training

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Midwifery students enrolled in the 3rd or 4th year of study.
  • Completed coursework in Child Health and Diseases Nursing and Neonatal Health.
  • Literate in Turkish.
  • Voluntarily agreed to participate and provided written and/or verbal informed consent.

You may not qualify if:

  • Withdrew participation before completing data collection.
  • Missing pre-test or post-test data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Faculty of Health Sciences, Department of Midwifery

Erzurum, Yakutiye, 25000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study was open-label. Neither participants nor researchers were blinded to group assignments, as the educational intervention required active participation and observation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were stratified by class year and randomly assigned to either the intervention group (baby massage training) or control group (no training). The study followed a parallel design with pre-test and post-test evaluation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Dr., Department of Midwifery

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 26, 2025

Study Start

April 2, 2024

Primary Completion

May 6, 2024

Study Completion

June 9, 2024

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

This study involved educational interventions among students and collected only anonymized group data. No individual participant data (IPD) will be shared.

Locations