RecruitingNot ApplicableNCT06438731

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

The Effect of Breast Milk and Knitted Octopus on the Pain Caused by Orogastric Tube Insertion in Preterm Newborns


Sponsor

Pamukkale University

Enrollment

66 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 32 WeeksMax Age: 34 Weeks

Inclusion Criteria8

  • 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 Criteria5

  • 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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Interventions

OTHERBREAST MILK

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

OTHERKNITTED OCTOPUS

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


Locations(1)

Pamukkale University Hospital

Denizli, Pamukkale, Turkey (Türkiye)

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NCT06438731


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