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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Behavioral: Comparisons of procedural 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

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2019-08-30
• Study Completion: 2019-09-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-16
• Last Update Submitted: 2020-06-16
• Study First Posted: 2020-06-17
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraclass Correlation between the NIPS Score of Parent, Nurse	Comparisons of procedural pain	Intraclass Correlation between the NIPS Score of Parent, Nurse
Comparisons of procedural pain scores among groups	Comparisons of procedural pain	Comparisons of procedural pain scores among groups

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

Trial Locations

Locations (1)

İnonu Üniversity; 🇹🇷 Malatya, Turkey