NCT06204146

Brief Summary

The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress. While the population of the research is preterm infants at the neonatal intensive care unit of a Medicalpark Batman Hospital between January 2018 and February 2019, the sample is 60 preterm infants suitable for inclusion criteria. Research data was collected using Preterm Infant Information Form, Preterm Follow-up Form and Newborn Stress Scale. While massage was applied to the infants in the experimental group three times daily for 10 days, the control group received the usual care. Weight, length and head circumference of infants in both experimental and control group were measured by the researcher on 1., 5. and 10. days. In order to evaluate stess level of the massage applied infants, camera records of the infants were taken 15 minutes before and after the massage on 1., 5. and 10. days. Camera records of the infants in the control group were also taken at the same time with those in the experimental group. Camera records were watched and stress level of the infants were evaluated by two observers blind to the research. The data analyses were carried out using In-class Correlation, Frequency, Levene, Two-Way ANOVA for Mixed Measured, Repeated ANOVA tests

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration 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

May 24, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

October 24, 2023

Last Update Submit

December 3, 2025

Conditions

Keywords

preterm

Outcome Measures

Primary Outcomes (4)

  • Weight

    physiological parameter is analyzed, it is observed first day and ten day the baby weight

    10 days

  • length

    physiological is analyzed, it is observed first day and ten day the baby length

    10 days

  • head circumference

    physiological parameter is analyzed, it is observed first day and ten day the baby head circumference

    10 days

  • newborn stres scale

    it is an assessment tool developed to evaluate the stress level of newborn. 0-2 point each item min max 16point each subscale

    10 days

Study Arms (2)

massage

EXPERIMENTAL

massage was applied to the infants in the experimental group three times daily for 10 days,

Behavioral: massage

control

NO INTERVENTION

the control group received the usual care

Interventions

massageBEHAVIORAL

stressn level and preterm growth

massage

Eligibility Criteria

Age27 Weeks - 36 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- Gestational age at birth below 36 weeks + 6 days, Body weight over 1000 g, Do not have any diseases or congenital disorders, Babies who are allowed to be massaged by the NICU's neonatologist was determined as .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emine Sarıkamış Kale

Batman, Merkez, 72000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Massage

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • emine sarıkamış kale, MSc

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Phd student

Study Record Dates

First Submitted

October 24, 2023

First Posted

January 12, 2024

Study Start

May 24, 2017

Primary Completion

June 7, 2019

Study Completion

July 10, 2019

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations