Reducing pain during heel blood collection in preterm newborns
Evaluation of the Effect of Fetal Position, Kangaroo Care, Breast Milk and Combined Fetal Position and Kangaroo Care in Reducing Pain During Heel Blood Collection in Preterm Newborns.
This study is testing different gentle methods, like holding babies close and using breast milk, to see if they can help reduce pain during heel blood tests in late preterm newborns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 3 Days to 5 Days |
| Sex | All |
| Sponsor | Suleyman Demirel University Academic / other |
| Locations | 1 site (Isparta) |
| Trial ID | NCT05431452 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of various non-pharmacological methods, such as kangaroo care, breast milk, and fetal positioning, in reducing pain during heel blood collection in late preterm newborns. The research involves randomizing 40 babies into different intervention groups to assess their physiological responses during the procedure. Data will be collected through video recordings and analyzed using the PIPP-R scale by independent observers. The goal is to enhance pain management practices in neonatal intensive care units.
Who should consider this trial
Good fit: Ideal candidates for this study are late preterm newborns between 34 and 36 weeks of gestation who are stable and able to take breast milk.
Not a fit: Patients who are receiving mechanical ventilation, have congenital anomalies, or are on analgesic medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques for preterm newborns during minor invasive procedures.
How similar studies have performed: Other studies have shown success with non-pharmacological pain management approaches in neonatal care, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestation week between 34(0)/7 - 36(6)/7 weeks * Stable physiological condition * Able to maintain spontaneous breathing * Able to take breast milk * Not exposed to a painful procedure at least half an hour before the intervention. * Late preterm newborns not taking opioid or non-opioid analgesics will be included in the -study. Exclusion Criteria: * Receiving mechanical ventilator support * Congenital anomaly * Using analgesic/narcotic analgesic drugs * Babies who receive treatment with continuous sedation will not be included in the study.
Where this trial is running
Isparta
- Suleyman Demirel University — Isparta, Turkey (Recruiting)
Study contacts
- Principal investigator: Şerife Tutar — Suleyman Demirel University
- Study coordinator: Şerife Tutar
- Email: serifeguven@sdu.edu.tr
- Phone: +905053126429
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.