Effect of Baby Massage on Oral Motor Skills of Premature Babies

March 11, 2024 updated by: Nazire Arat, Ege University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Turkey
    • Bornova
      • Izmir, Bornova, Turkey, 35040
        • Ege University

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:

  • 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.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group of baby massage
Being between 28-33 weeks of gestation, Not having a congenital disease, Meeting the readiness criteria for oral feeding, Must be in the weight range of 1000-2000 grams
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.
Experimental: Group of oral stimulation (Fucile Protocol)
Being between 28-33 weeks of gestation, Not having a congenital disease, Meeting the readiness criteria for oral feeding, Must be in the weight range of 1000-2000 grams
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time for first oral feeding
Time Frame: up to 36th week of gestation
assessment of feeding skills
up to 36th week of gestation
time for full oral feeding
Time Frame: up to 38th week of gestation
assessment of feeding skills
up to 38th week of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
discharge time
Time Frame: up to 40th week of gestation
time to hospital discharge (related to feeding ability)
up to 40th week of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege 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)

September 1, 2021

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ege üniversitesi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I want to think about sharing

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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