Reducing pain during vaccinations in infants using non-drug methods
The Effect of Breastfeeding and Maternal Holding on Reducing Pain During Vaccination in Infants
This study tests if holding and breastfeeding can help reduce pain for healthy infants getting vaccinated.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 1 Month to 6 Months |
| Sex | All |
| Sponsor | University of Yalova Academic / other |
| Locations | 1 site (Yalova) |
| Trial ID | NCT06886412 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of non-pharmacological methods, specifically maternal holding and breastfeeding, in reducing pain experienced by infants during vaccinations. It aims to assess how these interventions can help infants cope with pain in a safe and cost-effective manner. The study involves healthy infants aged 4 weeks to 6 months who are scheduled for vaccination and have not received any analgesics prior to the procedure. By utilizing a randomized controlled design, the research seeks to provide evidence for best practices in infant pain management during vaccinations.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants aged between 4 weeks and 6 months who are scheduled for vaccination.
Not a fit: Patients who may not receive benefit from this study include those with chronic or mental illnesses, congenital anomalies, or those older than 6 months.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for infants during vaccinations, enhancing their overall vaccination experience.
How similar studies have performed: Other studies have shown success with similar non-pharmacological approaches to pain management in infants, indicating a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being healthy, * Aged between 4 weeks and 6 months, * Parents have given verbal and written consent to participate in the study, * Born at term (37 weeks of gestation or later), * Scheduled for vaccination under the Ministry of Health's vaccination program, * Not having taken analgesics/antipyretics in the last 4 hours before the procedure, * Having a normal body temperature (between 36.5°C and 37.1°C). Exclusion Criteria: * Having a chronic or mental illness, or a congenital anomaly, * Being older than 6 months, * Having a body temperature above 37.1°C, * Receiving analgesics, sedatives, or any other medication.
Where this trial is running
Yalova
- Yalova University — Yalova, Turkey (Recruiting)
Study contacts
- Principal investigator: EMEL AVÇİN, Doctor — Yalova Unıversıty
- Study coordinator: EMEL AVÇİN, Doctor
- Email: emel.avcin@yalova.edu.tr
- Phone: 05534524243
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.