Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.

Study Overview
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Brief Summary
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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.

Official Title
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Conducted to Determine and Compare the Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Comparisons of procedural pain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Characteristics of newborns included<br>Characteristics of newborns included in the randomized controll | |
| Experimental: Intraclass Correlation between the NIPS Score of Parent, Nurse<br>Intraclass Correlation between the NIPS Score of Parent, Nurse | Behavioral: Comparisons of procedural pain<br>* This randomized experimental study with placebo and control groups<br>|
| Experimental: Comparisons of procedural pain scores among groups<br>Comparisons of procedural pain scores among groups | Behavioral: Comparisons of procedural pain<br>* This randomized experimental study with placebo and control groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Infant Pain Scale (NIPS) | 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 | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, infants