Actively Recruiting

Phase Not Applicable
Age: 32Weeks - 34Weeks
All Genders
NCT06438731

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

Led by Pamukkale University · Updated on 2024-06-03

66

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 32Weeks - 34Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational week between 32-34 weeks
  • Postnatal age 37 weeks or less
  • Having breast milk available
  • Weighing 1000 grams or more
  • Breathing spontaneously
  • Being fed with an orogastric tube
  • Not exposed to a painful procedure at least 30 minutes before interventions
  • Parental consent provided for participation
Not Eligible

You will not qualify if you...

  • Received ventilator support (current or previous)
  • Any congenital anomaly of the face or oral cavity
  • Grade 3 or 4 intraventricular hemorrhage
  • Taking opioid or non-opioid pain medications
  • Repeated orogastric tube placements

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pamukkale University Hospital

Denizli, Pamukkale, Turkey (Türkiye), 20160

Actively Recruiting

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Research Team

M

Melek Nur GÜZEL

CONTACT

S

Sebahat ALTUNDAĞ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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