Conducted to Determine and Compare the Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Inonu University
- Enrollment
- 175
- Locations
- 1
- Primary Endpoint
- Neonatal Infant Pain Scale (NIPS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Aim: This study was conducted to determine and compare the effectiveness of different non-pharmacological methods in pain management during vaccination.
Methods: This randomized experimental study with placebo and control groups was conducted with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35), sucrose (n = 35), sucrose-placebo (n = 35) and control (n = 35) groups. The pain levels of the infants were determined by blind assessors (nurses, parents, and observer) using the Neonatal Infant Pain Scale (NIPS) before and during vaccination.
Investigators
Emriye Hilal Yayan
associate professor
Inonu University
Eligibility Criteria
Inclusion Criteria
- •Born at full term
- •No infection, redness, deteriorated skin integrity, or nerve damage in the area of application
- •Had not undergone any clinical injection.
Exclusion Criteria
- •Infants who have applied analgesics before the vaccination
Outcomes
Primary Outcomes
Neonatal Infant Pain Scale (NIPS)
Time Frame: 10 minutes
NIPS is a valid behavioural instrument that can be used to assess infants' response to pain. NIPS includes six behavioural responses to pain: facial expression, crying, breathing patterns, arms, legs, and state of wakefulness. The total pain scores range from 0 to 7. While the internal consistency of the original NIPS is within the range of .87 to .95, the internal consistency of the Turkish version is .83