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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İnonu Üniversity

Malatya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparisons of procedural pain

Behavioral

This randomized experimental study with placebo and control groups

Primary outcomes

Neonatal Infant Pain Scale (NIPS)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Jun 17, 2020
Registry last updated: Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed