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Recruiting NCT06438731

Comparison of Two Methods in Pain Caused by Orogastric Tube Placement in Preterm Newborns

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Trial Parameters

Condition Pain
Sponsor Pamukkale University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 66
Sex ALL
Min Age 32 Weeks
Max Age 34 Weeks
Start Date 2024-03-29
Completion 2026-03
Interventions
BREAST MILKKNITTED OCTOPUS

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Brief Summary

Aim : This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm newborns. Method : This study was planned as a randomized controlled trial. The study group will consist of 66 preterms with a gestational age of 32-34 weeks fed by orogastric tube. Informed Consent Form, Preterm Newborn Introduction Form, Physiologic Parameters Measurement Form and Premature Infant Pain Profile (PIPP) will be used in the study. The research will be conducted in the Neonatal Intensive Care Unit of a university hospital in Denizli province. Newborns in the breast milk group will be given oral breast milk before the procedure. Newborns in the knitted octopus group will be provided with the octopus touching various parts of their bodies as a tactile stimulation before the procedure. No intervention will be performed on newborns in the control group. Data will be obtained by the researcher from camera recording and patient file. In evaluating the data, continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Parametric and non-parametric tests will be used to examine the differences between groups. Hypothesis: It is expected to contribute to the development of a new approach in the pain management of preterm newborns by evaluating the effectiveness of breast milk and knitted octopus in reducing the pain caused by orogastric tube insertion in preterm newborns.

Eligibility Criteria

Inclusion Criteria: * Gestational week between 32-34 weeks * Postnatal age ≤ 37 weeks * Having breast milk * Weighing 1000 grams or more * Spontaneous breathing * Being fed with an orogastric tube * Not being exposed to a painful procedure at least half an hour before the interventions * Parental consent for the newborn to participate in the study Exclusion Criteria: * Having received ventilator support (may have received it before) * Any congenital anomaly of the face or oral cavity * Grade 3 and 4 intraventricular hemorrhage * Taking opioid or non-opioid analgesics * Repeated orogastric tube placement

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