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

University of Bamenda

Status: Completed

Conditions: Pain Management

Treatments: Procedure: Massage; Dietary Supplement: Breastmilk

Study type: Interventional

Funder types: Other

Identifiers

NCT06879613

2024/0030H/UBa/IRB

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 6 to 6 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

Breastmilk arm

Experimental group

Description:

Breastmilk was administered for pain

Treatment:

Dietary Supplement: Breastmilk

Massage arm

Experimental group

Description:

Massage was administered for pain

Treatment:

Procedure: Massage

No interention arm

No Intervention group

Description:

No intervention was done for pain