Pain ManagementNCT06879613
Comparing Breastmilk, Massage, and no Intervention for Pain Management During Vaccination of Term Infants
A study testing Breastmilk and Massage in people with Pain Management, run by University of Bamenda at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 6 weeks
- Conditions the study is for
- Pain Management
- What is being tested?
- Breastmilk and Massage
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Feb 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 6 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Breastmilk, Massage, and no Intervention for Pain Management During Vaccination of Term Infants at the Bamenda Regional Hospital
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
- Being tested
- Breastmilk, Massage
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastmilkDietary supplement
Breastmilk from the mother of the infant was given for pain
MassageProcedure or surgery
The spot that was vaccinated was massaged by the mother/carer of the infant
| Study group | Role | What they receive |
|---|---|---|
| Breastmilk arm | Experimental | Breastmilk was administered for pain Receives: Dietary Supplement: Breastmilk |
| Massage arm | Experimental | Massage was administered for pain Receives: Procedure: Massage |
| No interention arm | No intervention | No intervention was done for pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The pain scores for all the arms was done 2 minutes before vaccination and 30 seconds after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Feb 2024
- Primary completion30 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bamenda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879613
- Sponsor's protocol ID
- 2024/0030H/UBa/IRB
- Status last verified
- Mar 2025
- First submitted
- 6 Dec 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Breastmilk, Massage, and no Intervention for Pain Management During Vaccination of Term Infants at the Bamenda Regional Hospital
- ClinicalTrials.gov ID
- NCT06879613
- Acronym / sponsor ID
- 2024/0030H/UBa/IRB
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of BamendaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breastmilk arm | Experimental | Dietary Supplement: BreastmilkBreastmilk was administered for pain |
| Massage arm | Experimental | Procedure: MassageMassage was administered for pain |
| No interention arm | No intervention | –No intervention was done for pain |
Who may qualify
- Ages
- 6 to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreastmilkBreastmilk from the mother of the infant was given for pain | Dietary supplement | Breastmilk arm |
| MassageThe spot that was vaccinated was massaged by the mother/carer of the infant | Procedure or surgery | Massage arm |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastmilk and Massage in people with Pain Management, run by University of Bamenda at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.