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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 7 months
Maximum Age: 7 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Pamukkale University Hospital
RECRUITING
Denizli
Contact Information
Primary
Melek Nur GÜZEL
makyol162@posta.pau.edu.tr
5346247995
Backup
Sebahat ALTUNDAĞ
saltundag@pau.edu.tr
Time Frame
Start Date: 2024-03-29
Estimated Completion Date: 2026-03
Participants
Target number of participants: 66
Treatments
Active_comparator: Breast Milk Group
Preterm newborns in this group will be administered their own mother's milk with a sterile syringe as 1 ml single dose 2 minutes before orogastric tube insertion. During administration, the baby will not be allowed to suck the tip of the syringe and breast milk will be dripped onto the tongue. Nothing oral will be given 30 minutes before the procedure.
Active_comparator: Knitted Octopus Group
The knitted octopus method will be applied to preterm newborns in this group before orogastric tube insertion. The arms of the knitted octopus will wrap around the baby's arms and legs, and its head will be on the baby's body.
No_intervention: Control Group
For preterm newborns in this group, no method will be applied before orogastric tube insertion and routine procedures will be performed.
Related Therapeutic Areas
Sponsors
Leads: Pamukkale University

This content was sourced from clinicaltrials.gov