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

Comparing Breastmilk, Massage, and no Intervention for Pain Management During Vaccination of Term Infants at the Bamenda Regional Hospital

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.

Study Overview

• Status: Completed
• Conditions: Pain Management
• Intervention / Treatment: Dietary supplement: Breastmilk; Procedure: Massage

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cameroon
  • Northwest Region
    • Bamenda, Northwest Region, Cameroon, 00000
      • Bamenda Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breastmilk arm; Breastmilk was administered for pain	Dietary supplement: Breastmilk; Breastmilk from the mother of the infant was given for pain
Experimental: Massage arm; Massage was administered for pain	Procedure: Massage; The spot that was vaccinated was massaged by the mother/carer of the infant
No Intervention: No interention arm; No intervention was done for pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal infant pain score (NIPS)	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.	The pain scores for all the arms was done 2 minutes before vaccination and 30 seconds after vaccination

Collaborators and Investigators

• Sponsor: University of Bamenda

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024/0030H/UBa/IRB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No