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

Inonu University

Status: Completed

Conditions: Pain

Treatments: Behavioral: Comparisons of procedural pain

Study type: Interventional

Funder types: Other

Identifiers

NCT04436185

interventional

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: Under 8 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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175 participants in 3 patient groups

Characteristics of newborns included

No Intervention group

Description:

Characteristics of newborns included in the randomized controll

Intraclass Correlation between the NIPS Score of Parent, Nurse

Experimental group

Description:

Intraclass Correlation between the NIPS Score of Parent, Nurse

Treatment:

Behavioral: Comparisons of procedural pain

Comparisons of procedural pain scores among groups

Experimental group

Description:

Comparisons of procedural pain scores among groups

Treatment:

Behavioral: Comparisons of procedural pain