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

NCT06438731 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-06-03

No results posted yet for this study

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.

Conditions

Interventions

OTHER

BREAST MILK

The preterm will be monitored for 5 minutes before birth, during the procedure cycle, and then by camera recording for 5 minutes

OTHER

KNITTED OCTOPUS

The preterm will be monitored for 5 minutes before birth, during the procedure cycle, and then by camera recording for 5 minutes

Sponsors & Collaborators

  • Pamukkale University

    lead OTHER

Principal Investigators

  • Melek Nur GÜZEL · BAĞLANTISIZ

  • Sebahat ALTUNDAĞ · BAĞLANTISIZ

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

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 NCT06438731 on ClinicalTrials.gov