Actively Recruiting
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
Eligibility Criteria
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
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
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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