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

NCT ID: NCT06879613

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Breastmilk arm

Breastmilk was administered for pain

Group Type EXPERIMENTAL

Breastmilk

Intervention Type DIETARY_SUPPLEMENT

Breastmilk from the mother of the infant was given for pain

Massage arm

Massage was administered for pain

Group Type EXPERIMENTAL

Massage

Intervention Type PROCEDURE

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

No interention arm

No intervention was done for pain

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Breastmilk

Breastmilk from the mother of the infant was given for pain

Intervention Type DIETARY_SUPPLEMENT

Massage

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

6 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bamenda

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bamenda Regional Hospital

Bamenda, Northwest Region, Cameroon

Site Status

Countries

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Cameroon

Other Identifiers

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2024/0030H/UBa/IRB

Identifier Type: -

Identifier Source: org_study_id

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