Effects of Vibration, Heel Warming, and Shotblocker on Pain During Heel Blood Collection in Newborns
Effects of Vibration, Heel Warming and Shotblocker on Pain Levels During Heel Blood Collection: A Randomized Controlled Study
NA · Burdur Mehmet Akif Ersoy University · NCT06646848
This study is testing whether using vibration, warming the heel, or a special device can help reduce pain during heel blood tests in healthy newborns.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 2 Days to 4 Days |
| Sex | All |
| Sponsor | Burdur Mehmet Akif Ersoy University (other) |
| Locations | 1 site (Burdur, Bucak) |
| Trial ID | NCT06646848 on ClinicalTrials.gov |
What this trial studies
This prospective randomized controlled trial aims to evaluate the effectiveness of three non-pharmacological interventions—Vibration, Heel Warming, and Shotblocker—in reducing pain levels during heel blood collection in healthy term newborns. A total of 120 newborns will be randomly assigned to one of four groups: Vibration, Heel Warming, Shotblocker, or a Control group. Pain levels will be assessed using the Neonatal Infant Pain Scale (NIPS) after the heel stick procedure, which will be performed by an experienced nurse in a controlled environment. The study seeks to provide evidence for effective pain management techniques in neonatal care.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy term newborns aged 2 to 4 days who are undergoing heel stick blood drawing for metabolic screening.
Not a fit: Patients who may not benefit from this study include those with chronic diseases, congenital anomalies, or whose parents cannot provide informed consent.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for newborns undergoing routine blood collection.
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, PhD. — 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.
Conditions: Newborn, Pain Management, Vibration, Heel Warming, Shotblocker, Wounds, Penetrating, Needlestick Injuries, Pain