Intramuscular Injection-Related Pain and Fear

NCT03915704 | Completed DMC

• 1 other identifier: 07112018139
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an experimental randomized controlled study conducted to compare the effect of buzzy and shotblocker methods applied during intramuscular injection from on pain and fear level in 6-12 year-old children. The sample of the study consisted of 90 children aged between 6 and 12 years who were diagnosed with upper and lower tract respiratory infections and received intramuscular injection of ceftriaxone at the pediatric emergency department of a university hospital in İstanbul between November 2018 and April 2019. The children were divided into 3 groups of 30 people, including shotblocker, buzzy, and control groups. Each intervention and control group was matched in terms of gender. In the study, the randomization of the sample group was performed by using stratification and block randomization methods.

Conditions

Pain; Fear

Keywords

pain management; intramuscular injection; non-pharmacological method

Outcome Measures

Primary Outcomes (1)

• Pain severity

  The pain level of children before and after the injection was assessed using Wong-Baker FACES Pain Rating Scale. To assess the pain level of the children, the children were asked to evaluate themselves, and their parents and first researcher were requested to evaluate the children's pain level immediately before and after the injection. The responses of the children, their parents, and the first researcher were scored blindly. This scale has the faces and the pain score is determined according to the numerical values given to the faces. While smiley face "0 point" shows lack of pain, crying face "10 points" refer to severe pain (Merkel \& Malviya, 2000). The validity and reliability of this scale was conducted

  5 Months

Secondary Outcomes (1)

• Fear Levels

  5 Months

Study Arms (3)

Buzzy

EXPERIMENTAL

Buzzy was placed 3-5 cm above the injection site 60 sec before the injection and used until the procedure was completed. The Buzzy application to all children in this group was done by the second researcher. After the injection, the ice pack was wiped with 70% alcohol and frozen again by freezing.

Device: Buzzy

Shotblocker

EXPERIMENTAL

ShotBlocker is a small, flat, yellow horseshoe-shaped plastic tool that is non-invasive, appropriate for every age group, does not have the characteristics of medication or adverse effects. ShotBlocker has short, blunt points that provide contact with skin on one side, and a hole that exposes the injection site in the middle of the tool. It is used by being held on the skin surface during injection. The pointed surface of the tool is placed on the administration area right before the injection

Device: Shotblocker

Control

EXPERIMENTAL

No intervention was performed to reduce pain and fear in the control group.

Procedure: Control

Interventions

Shotblocker DEVICE

Injection was administered with ShotBlocker.The Shotblocker application to all children in this group was done by the second researcher. After the injection, the shotblocker was wiped with 70% alcohol.

Shotblocker

Control PROCEDURE

No intervention was made in the children.

Control

Buzzy DEVICE

Buzzy was placed 3-5 cm above the injection site 60 sec before the injection and used until the procedure was completed.The Buzzy application to all children in this group was done by the second researcher. After the injection, the ice pack was wiped with 70% alcohol and frozen again by freezing.

Buzzy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• being aged between 6-12,
• requiring for ceftriaxone intramuscular injection because of upper and lower respiratory tract infections,
• being cognitively able to rate pain and fear scales, and voluntariliy signing the written informed consent.

You may not qualify if:

• having a disease causing chronic pain,
• receiving analgesics within the last 6 hours, with pacemakers,
• having infection, rash, or detoriorated skin integrity in the site where the injection was to be made, had nerve damage in the injection site,
• having critical or unstable health status, had intellectual disability, reynaud's syndrome, and sickle cell disease
• being unwilling to participate in the study.

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Saglik Bilimleri University

Istanbul, 34660, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Burcu Aykanat Girgin, PhD RN

  Saglik Bilimleri University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD RN, Assistant Professor

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: November 1, 2018
• Primary Completion: March 29, 2019
• Study Completion: April 8, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

TU (1)