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

NCT06879613 | Completed

• 1 other identifier: 2024/0030H/UBa/IRB
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Outcome Measures

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.

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

Study Arms (3)

Breastmilk arm

EXPERIMENTAL

Breastmilk was administered for pain

Dietary Supplement: Breastmilk

Massage arm

EXPERIMENTAL

Massage was administered for pain

Procedure: Massage

No interention arm

NO INTERVENTION

No intervention was done for pain

Interventions

Breastmilk DIETARY_SUPPLEMENT

Breastmilk from the mother of the infant was given for pain

Breastmilk arm

Massage PROCEDURE

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

Massage arm

Eligibility Criteria

• Age: 6 Weeks - 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bamenda: lead

Study Sites (1)

Bamenda Regional Hospital

Bamenda, Northwest Region, 00000, Cameroon

Location

MeSH Terms

Conditions

Agnosia

Interventions

Massage

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: March 17, 2025
• Study Start: February 1, 2024
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

CA (1)