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

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.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

6 week–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bamenda Regional Hospital

Bamenda, Northwest Region, 00000, Cameroon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breastmilk

Dietary Supplement

Breastmilk from the mother of the infant was given for pain

Massage

Procedure

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

Primary outcomes

Neonatal infant pain score (NIPS)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Bamenda

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Mar 17, 2025
Registry last updated: Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed