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Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol with Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose

NCT05180058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-01-10

No results posted yet for this study

Summary

This study aimed to reduce the pain and increase comfort during the orogastric tube insertion (OGT) procedure, which is routinely applied to feed these babies at 32-34 weeks of age, in preterm newborns with a sucking reflex.In addition, this study also aimed to develop an atraumatic OGT attachment protocol by combining wrapping, fetal position, breast milk and oral sucrose combined therapy.

It was planned as a randomized double-blind and controlled experimental study to evaluate the efficacy of using In addition, this study also planned to develop the atraumatic OGT insertion procedure through combined therapy of wrapping, fetal position, breast milk, and oral sucrose. The population of the research consists of preterm babies who are treated in the Neonatal Intensive Care Unit of Selcuk University Hospital. Babies to be sampled are preterm babies who are between 32 and 34 weeks of gestation.

Preterm newborns will be randomly divided into five groups;

* Group 1: Control
* Group 2: Wrapping + breast milk (2 ml)
* Group 3: Wrapping + oral sucrose (0.2 ml/kg 20% sucrose)
* Group 4: Fetal position + breast milk (2 ml)
* Group 5: Fetal position + oral sucrose (0.2 ml/kg 20% sucrose) In the NICU, OGT insertion will be performed by the clinical nurse as part of the treatment for preterm newborns, which the clinic physician deems necessary. The clinical nurse and clinician will be responsible for OGT insertion in preterm newborns. In this study, only wrapping, fetal positioning, oral breast milk and sucrose delivery methods will be applied to preterm newborns by the researcher. In this context, the responsibility of the researcher in the study will be to apply non-pharmacological methods to preterm newborns only before OGT insertion and to evaluate the pain symptoms in preterm newborns during and after OGT insertion.

The obtained data will be evaluated in SPSS-21 package program in computer environment. Normality tests, chi-square, t test, Anova, and advanced analysis will be used when necessary in the analysis of the data. The relationship between the mean score of the scale and other variables will be evaluated by correlation regression analysis. Significance will be accepted as p\<0.05.

Conditions

  • Premature
  • Orogastric Tube
  • Oral Sucrose

Interventions

OTHER

Wrapping + Breastmilk Group

Interventions applied during orogastric tube insertion

Sponsors & Collaborators

  • Ayse Sonay Turkmen, Prof.Dr

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2022-06-30
Completion
2022-09-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180058 on ClinicalTrials.gov