Pain
Conditions
Keywords
pain, infants
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.
Interventions
BEHAVIORALComparisons of procedural pain
This randomized experimental study with placebo and control groups
Sponsors
Inonu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
In the study, a multi-stage randomization method was used as follows: 1) random selection of the family health centres in the city in which the research was conducted; 2) selection of the mothers and infants to be included in the study at each centre; and 3) selection of the groups to which the participants were assigned using a computer-based block randomization method (https://www.randomizer.org). The infants, randomized via a computer system, were assigned to the ShotBlocker® group (n= 35), ShotBlocker®-placebo group (n = 35), sucrose group (n = 35), sucrose-placebo group (n = 35), or the control group (n=35).
Intervention model description
This study was designed as a randomized experimental study with placebo and control groups in order to compare the effects of ShotBlocker® and sucrose on pain reduction during vaccine injections.
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed