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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06204146
Other study ID # 2017/015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2017
Est. completion date July 10, 2019

Study information

Verified date January 2024
Source Hasan Kalyoncu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 10, 2019
Est. primary completion date June 7, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 27 Weeks to 36 Weeks
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
massage
stressn level and preterm growth

Locations

Country Name City State
Turkey Emine Sarikamis Kale Batman Merkez

Sponsors (1)

Lead Sponsor Collaborator
EMINE SARIKAMIS KALE

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight physiological parameter is analyzed, it is observed first day and ten day the baby weight 10 days
Primary length physiological is analyzed, it is observed first day and ten day the baby length 10 days
Primary head circumference physiological parameter is analyzed, it is observed first day and ten day the baby head circumference 10 days
Primary 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
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