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

NCT04436185 | Completed

• 1 other identifier: interventional
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain; infants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Characteristics of newborns included

NO INTERVENTION

Characteristics of newborns included in the randomized controll

Intraclass Correlation between the NIPS Score of Parent, Nurse

EXPERIMENTAL

Intraclass Correlation between the NIPS Score of Parent, Nurse

Behavioral: Comparisons of procedural pain

Comparisons of procedural pain scores among groups

EXPERIMENTAL

Comparisons of procedural pain scores among groups

Behavioral: Comparisons of procedural pain

Interventions

Comparisons of procedural pain BEHAVIORAL

This randomized experimental study with placebo and control groups

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

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born at full term
• No infection, redness, deteriorated skin integrity, or nerve damage in the area of application
• Had not undergone any clinical injection.

You may not qualify if:

• Infants who have applied analgesics before the vaccination

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

İnonu Üniversity

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the study, a multi-stage randomization method was used as follows: 1) random selection of the family health centres in the city in which the research was conducted; 2) selection of the mothers and infants to be included in the study at each centre; and 3) selection of the groups to which the participants were assigned using a computer-based block randomization method (https://www.randomizer.org). The infants, randomized via a computer system, were assigned to the ShotBlocker® group (n= 35), ShotBlocker®-placebo group (n = 35), sucrose group (n = 35), sucrose-placebo group (n = 35), or the control group (n=35).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 17, 2020
• Study Start: July 1, 2019
• Primary Completion: August 30, 2019
• Study Completion: September 30, 2019
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)