Effect of leg and heel massage on pain during heel blood collection in newborns
Effect of Leg and Heel Massage on Pain Experienced During Heel Blood Collection and Physiological Parameters in Newborns: Randomized Controlled Study
This study tests if giving newborns a leg and heel massage before a heel prick for blood collection can help reduce their pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | Bartın Unıversity Academic / other |
| Locations | 1 site (Bartın, Province) |
| Trial ID | NCT06567093 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of leg and heel massage on reducing pain during heel blood collection in newborns. Infants will be randomly assigned to either a massage group, receiving a three-minute massage before the procedure, or a control group receiving routine care. Pain levels, heart rates, and oxygen saturation will be measured before, during, and after the blood collection. The goal is to determine if massage can effectively alleviate pain and improve physiological parameters in newborns undergoing this common procedure.
Who should consider this trial
Good fit: Ideal candidates are newborns aged 2-28 days, with a gestational age of 38-41 weeks and stable vital signs.
Not a fit: Patients who may not benefit include those requiring respiratory support or with neurological disorders, congenital anomalies, or who have undergone surgery.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve the overall experience of heel blood collection for newborns.
How similar studies have performed: Other studies have shown that non-pharmacological interventions like massage can effectively reduce pain in infants, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age is 38-41 weeks, * The birth weight of the newborn is \>2500 g * Vital signs should be stable before the procedure, * Postanatal age is between 2-28 days, * There are no contraindications for the application of massage * Delivery of the newborn to the mother after birth * Permission of the parents of the newborn participating in the research * Fasting period less than 3 hours/fed 30 minutes before * A newborn who does not cry before heel blood is taken Exclusion Criteria: * Newborns who need respiratory support, * Newborns with any neurological disorders (seizures) * Newborns using opioids or babies born to mothers using opioids * Newborns taking muscle relaxants, sedatives, analgesics * Babies with major congenital anomalies * Babies with an APGAR score of less than 7 in 5 minutes, * Newborns who have undergone any surgery * Newborns with birth trauma (especially rapid births) * There are situations that may prevent communication with parents (e.g. language problems). * problem) * Newborns planned to be transferred to another hospital
Where this trial is running
Bartın, Province
- Bartın University — Bartın, Province, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Aylin Kurt, PhD
- Email: aylinkurt67@gmail.com
- Phone: +905382087211
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.