Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.
- Conditions
- Pain
- Registration Number
- NCT04436185
- Lead Sponsor
- Inonu University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- Born at full term
- No infection, redness, deteriorated skin integrity, or nerve damage in the area of application
- Had not undergone any clinical injection.
- Infants who have applied analgesics before the vaccination
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Neonatal Infant Pain Scale (NIPS) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
İnonu Üniversity
🇹🇷Malatya, Turkey
İnonu Üniversity🇹🇷Malatya, Turkey