Comparing Breastmilk, Massage, and no Intervention for Pain Management During Vaccination of Term Infants

Not Applicable

Completed

• Conditions: Pain Management

• Registration Number: NCT06879613
• Lead Sponsor: University of Bamenda

Brief Summary

The goal of this clinical trial is to learn if breastmilk, massage or no intervention works for pain management during vaccination of term infants. It will also learn about the safety of these 3 approaches. The main questions it aims to answer is:

Does breastmilk, massage or no intervention works for pain management during vaccination of term infants?

Researchers will compare breastmilk, massage or no intervention for pain management during vaccination of term infants.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-03-30
• Study Completion: 2024-04-30
• Study First Submitted: 2024-12-06
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Neonates born at or after 37 completed weeks of gestation.
• Neonates scheduled to receive the DTC-HepB-Hib-1 immunization.
• Time from last feeding should be greater than or equal to 30 minutes.

Exclusion Criteria

• Term neonates with major congenital abnormalities like limb contractures, limb deformities.
• Term neonates with any neurological conditions like hydrocephalus, cerebral palsy or birth asphyxia.
• Infants with acute illness.
• Infants randomized for no intervention but mothers breastfeed before pain evaluation to calm the babies from crying.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neonatal infant pain score (NIPS)	The pain scores for all the arms was done 2 minutes before vaccination and 30 seconds after vaccination	The pain score assessment based on the neonatal infant pain score (NIPS). Interpretation: minimum score of 0 and a maximum score of 7. 0-1: no pain; 2: mild pain; 3-4: moderate pain; 5-7: severe pain.

Trial Locations

Locations (1)

Bamenda Regional Hospital; 🇨🇲 Bamenda, Northwest Region, Cameroon