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Completed

NCT Number: NCT06308471

Effect of Baby Massage on Oral Motor Skills of 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.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Bornova, 35040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baby massage was applied to the intervention group (n=20) of the study

Other

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

Other

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.

Primary outcomes

  1. time for first oral feeding

    Time frame: up to 36th week of gestation

    assessment of feeding skills

  2. time for full oral feeding

    Time frame: up to 38th week of gestation

    assessment of feeding skills

Secondary outcomes

  1. discharge time

    Time frame: up to 40th week of gestation

    time to hospital discharge (related to feeding ability)

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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