Effect of Baby Massage on Oral Motor Skills of Premature Babies

Infant, Premature Clinical Trial

Official title:

The Effect of Baby Massage on Oral Motor Coordination Ability in Premature Babies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06308471
• Other study ID #: ege üniversitesi
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2024
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This experimental research was conducted in a single-blind, block randomized controlled design type. The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey. As a result of the power analysis, baby massage was applied to the intervention group (n = 20) and oral stimulation with the Fucile protocol was applied to the control group (n = 20). Comparative results were evaluated statistically.

Description:

The Effect of Baby Massage on Oral Motor Coordination Ability in Prematures Purpose: The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey. Method: The research was a single-blind, block randomized controlled design type and data was collected between September 2021 and May 2023. Baby massage was applied to the intervention group (n=20) of the study, and oral stimulation was applied with the Fucile protocol to the control group (n=20). The applications were applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale. Descriptive statistical methods, Fisher test, chi-square analysis, dependent and independent t test, Mann Whitney U test, one-way analysis of variance, Kruskal Wallis test, Pearson and Spearman correlations were used to evaluate the research results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

Inclusion Criteria:

• Being between 28-33 weeks of gestation,
• Not having a congenital disease,
• Clinical findings are stable and normal,
• It meets the readiness criteria for oral feeding,
• Being fed at full dose via Oral/Nasogastric tube and having never attempted oral intake before,
• It must weigh between 1000-2000 grams
• Parents give their consent to participate in the research and record video.

Exclusion Criteria:

• Premature babies of parents who did not give consent to participate in the study,
• Premature babies of parents who gave up participating in the study at any stage of the study,
• Physiological stability was impaired during the data collection process; Premature babies who require oxygen support and/or mechanical respirators,
• Conditions that disrupt clinical stability such as intracranial bleeding, necrotizing enterocolitis, neonatal sepsis are included in the process.

Related Conditions & MeSH terms

• Infant, Premature
• Premature Birth

Intervention

Other:
• Baby massage was applied to the intervention group (n=20) of the study
The application was applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale without knowing the application group of the babies.
• Oral stimulation
The application was applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale without knowing the application group of the babies.

Locations

Country	Name	City	State
Turkey	Ege University	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time for first oral feeding	assessment of feeding skills	up to 36th week of gestation
Primary	time for full oral feeding	assessment of feeding skills	up to 38th week of gestation
Secondary	discharge time	time to hospital discharge (related to feeding ability)	up to 40th week of gestation