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

University of Bamenda102 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

102

Conditions

Pain Management

Interventions

BreastmilkDIETARY_SUPPLEMENT

Breastmilk from the mother of the infant was given for pain

MassagePROCEDURE

The spot that was vaccinated was massaged by the mother/carer of the infant

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 6 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

Bamenda Regional Hospital

Bamenda, Northwest Region, Cameroon

Outcomes

Primary Outcomes

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.

Time frame: The pain scores for all the arms was done 2 minutes before vaccination and 30 seconds after vaccination

Data from ClinicalTrials.gov

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