Vaccination order and Pain response in Newborns
Phase 2
Completed
- Registration Number
- CTRI/2010/091/000426
- Lead Sponsor
- SR Ravikiran
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 68
Inclusion Criteria
Randomized study of full term healthy newborns who received the routine dose of BCG and the Hepatitis-B vaccine in the vaccination room of Pediatric Department; KVG Medical College Hospital; Sullia.
Exclusion Criteria
We excluded sick newborns , 5 minute APGAR<7, low birth weight babies, and those who were discharged before the weekly vaccination day.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure was the neonatal pain. Pain assessment was done using the neonatal infant pain scale (NIPS).Timepoint: it was measured prior to the vaccine injections and during the vaccine injections.
- Secondary Outcome Measures
Name Time Method 10-cm visual analog scale (VAS)Timepoint: Obtained immediately after the first and second vaccine injections.