Comparing breast milk and knitted octopus for pain relief during tube placement in preterm newborns
The Effect of Breast Milk and Knitted Octopus on the Pain Caused by Orogastric Tube Insertion in Preterm Newborns
This study is testing whether giving breast milk or a knitted octopus can help reduce pain for preterm newborns during tube placement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 32 Weeks to 34 Weeks |
| Sex | All |
| Sponsor | Pamukkale University Academic / other |
| Locations | 1 site (Denizli, Pamukkale) |
| Trial ID | NCT06438731 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two non-pharmacological interventions, breast milk and a knitted octopus, in reducing pain associated with orogastric tube insertion in preterm newborns. Conducted as a randomized controlled trial, it will involve 66 preterm infants aged 32-34 weeks who are fed via orogastric tube. Participants will be divided into three groups: one receiving oral breast milk, another receiving tactile stimulation from a knitted octopus, and a control group with no intervention. Pain levels will be assessed using the Premature Infant Pain Profile (PIPP) before and after the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm newborns between 32-34 weeks gestational age who are being fed via orogastric tube.
Not a fit: Patients who have received ventilator support or have congenital anomalies of the face or oral cavity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacological methods for pain management in preterm newborns during routine medical procedures.
How similar studies have performed: While there is limited literature directly comparing breast milk and knitted octopus for pain relief, both methods have shown promise in other contexts, making this approach innovative.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Denizli, Pamukkale
- Pamukkale University Hospital — Denizli, Pamukkale, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Melek Nur GÜZEL — Bağlantisiz
- Study coordinator: Melek Nur GÜZEL
- Email: makyol162@posta.pau.edu.tr
- Phone: 5346247995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.