Pain Management
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBreastmilk
Breastmilk from the mother of the infant was given for pain
PROCEDUREMassage
The spot that was vaccinated was massaged by the mother/carer of the infant
Sponsors
University of Bamenda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 6 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Cameroon
Outcome results
None listed