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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: Comparisons of procedural pain

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey
    • İnonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: pain; infants
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No