- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06204146
The Effect of Massage on Growth And Stress And Stress ,Department of Nursing,
December 3, 2025 updated by: EMİNE SARIKAMIŞ KALE
The Effect of Massage Applied to Preterm Infants On Growth and Stress
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
Study Overview
Detailed Description
The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merkez
-
Batman, Merkez, Turkey (Türkiye), 72000
- Emine Sarıkamış Kale
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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 .
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: massage
massage was applied to the infants in the experimental group three times daily for 10 days,
|
stressn level and preterm growth
|
|
No Intervention: control
the control group received the usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: 10 days
|
physiological parameter is analyzed, it is observed first day and ten day the baby weight
|
10 days
|
|
length
Time Frame: 10 days
|
physiological is analyzed, it is observed first day and ten day the baby length
|
10 days
|
|
head circumference
Time Frame: 10 days
|
physiological parameter is analyzed, it is observed first day and ten day the baby head circumference
|
10 days
|
|
newborn stres scale
Time Frame: 10 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: emine sarıkamış kale, MSc, Hasan Kalyoncu University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2017
Primary Completion (Actual)
June 7, 2019
Study Completion (Actual)
July 10, 2019
Study Registration Dates
First Submitted
October 24, 2023
First Submitted That Met QC Criteria
January 11, 2024
First Posted (Actual)
January 12, 2024
Study Record Updates
Last Update Posted (Actual)
December 10, 2025
Last Update Submitted That Met QC Criteria
December 3, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Obstetric Labor, Premature
- Obstetric Labor Complications
- Pregnancy Complications
- Premature Birth
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Massage
Other Study ID Numbers
- 2017/015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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