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CompletedNCT06879613Updated Mar 17, 2025

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

An interventional study of Breastmilk and Massage in Pain Management, sponsored by University of Bamenda. Completed at 1 site in Cameroon. Open to participants aged 6 Weeks to 6 Weeks. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by University of Bamenda · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Feb 2024, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
6 Weeks to 6 Weeks
Sex
All
01

Study 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.

02

Conditions studied

  • Pain Management
03

In context

Lead sponsor

University of Bamenda is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 6 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Breastmilk arm

    Breastmilk was administered for pain

    Dietary Supplement: Breastmilk

  • Experimental
    Massage arm

    Massage was administered for pain

    Procedure: Massage

  • No intervention
    No interention arm

    No intervention was done for pain

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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Bamenda Regional Hospital
    Bamenda, Northwest Region 00000, Cameroon
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2024 to primary completion in Mar 2024, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2024
First posted
Mar 17, 2025
StartActual
Feb 1, 2024
Primary completionActual
Mar 30, 2024
CompletionActual
Apr 30, 2024
Last update
Mar 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06879613
Lead sponsor
University of Bamenda
Responsible party
Sponsor
First posted
Mar 17, 2025
Start date
Feb 1, 2024
Primary completion
Mar 30, 2024
Completion
Apr 30, 2024
Last update
Mar 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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