Reducing pain during heel blood collection in newborns using breastfeeding and vibration
Determination of the Effects of Three Different Methods in Reducing Pain During Heel Blood Collection; Breastfeeding, Vibration, and Breastfeeding+Vibration: A Randomized Controlled Study
This study is testing if breastfeeding, vibration, or a combination of both can help reduce pain for newborns during heel blood collection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 2 Days to 4 Days |
| Sex | All |
| Sponsor | Burdur Mehmet Akif Ersoy University Academic / other |
| Locations | 1 site (Burdur, Bucak) |
| Trial ID | NCT06741670 on ClinicalTrials.gov |
What this trial studies
This prospective randomized controlled trial aims to evaluate the effectiveness of three non-pharmacological methods—Breastfeeding, Vibration, and a combination of both—in reducing pain during heel blood collection in healthy term newborns. A total of 200 newborns will be randomly assigned to one of four groups: Breastfeeding, Vibration, Breastfeeding+Vibration, and a Control group. Pain levels will be assessed using the Neonatal Infant Pain Scale (NIPS) after the heel stick procedure, which will be performed in a controlled environment by an experienced nurse. The study seeks to provide evidence on the best practices for pain management in newborns during routine medical procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy term newborns aged 2 to 4 days who are undergoing routine heel stick blood collection.
Not a fit: Patients who may not benefit from this study include those with chronic diseases or congenital anomalies.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques for newborns during invasive procedures.
How similar studies have performed: Other studies have shown success with similar non-pharmacological approaches to pain management in newborns, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parents who volunteered and gave consent to participate in the research * Full term neonates (38-42 weeks of gestation) * Underwent heel stick blood drawing for routine metabolic screening, * Aged 2 to 4 days * Passed the hearing screening * Birth weight between 2500-4400 grams * Parents who know how to read, write and speak Turkish. Exclusion Criteria: * Parents with any mental problems * Infants with any chronic disease and congenital anomalies.
Where this trial is running
Burdur, Bucak
- Burdur Mehmet Akif Ersoy University — Burdur, Bucak, Turkey (Recruiting)
Study contacts
- Principal investigator: Selda Ateş Beşirik — Burdur Mehmet Akif Ersoy University
- Study coordinator: Selda Ateş Beşirik, PhD.
- Email: seldaates07@gmail.com
- Phone: +905543683323
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.