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临床试验/NCT06308471
NCT06308471已完成不适用

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

Ege University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
time for full oral feeding

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Professional nurses who evaluate nutrition do not know which group they belong to in the study.

They do not know which group the premature babies are in due to their age.

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Group of baby massage

Experimental

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

干预措施: Baby massage was applied to the intervention group (n=20) of the study (Other)

Group of oral stimulation (Fucile Protocol)

Experimental

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

干预措施: Oral stimulation (Other)

结局指标

主要结局

time for full oral feeding

时间窗: up to 38th week of gestation

assessment of feeding skills

time for first oral feeding

时间窗: up to 36th week of gestation

assessment of feeding skills

次要结局

  • discharge time(up to 40th week of gestation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazire Arat

Principal Investigator

Ege University

研究点 (2)

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