Effect of Vibration and ShotBlocker on Pain and Fear Levels During Intramuscular Injection in Children in the Emergency Department

NCT07750626 | Recruiting

• 1 other identifier: GO 2026/2536
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study is planned as a randomized controlled study. The aim of this study is to investigate the effects of vibration and the ShotBlocker method on pain and fear levels in children during intramuscular injection in the emergency department.

Conditions

Children; Pain Management; Vibration; Shotblocker; Intramuscular Injection; Intramuscular Injection Pain

Keywords

Children; Pain; Vibration; ShotBlocker; Intramuscular Injection; Fear; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Wong-Baker FACES Pain Rating Scale

  In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.

  Through painful procedure completion, an average of 10 minutes

Secondary Outcomes (1)

• Children's Fear Scale

  Through painful procedure completion, an average of 10 minutes.

Study Arms (3)

Vibration Group

EXPERIMENTAL

Vibration was applied to the children in this group before and during the intramuscular Injection procedure.

Device: Vibration

Shotblocker Group

EXPERIMENTAL

ShotBlocker was applied to the children in this group before and during the intramuscular Injection procedure.

Device: Shotblocker

Control Group

NO INTERVENTION

In this group, child received routine intramuscular Injection procedure.

Interventions

Vibration DEVICE

The vibration device was operated for 30 seconds with reference to previous studies. While the vibration continued, the nurse with a needle.Then, the vibration device continued to work in the waiting phase for 10 seconds. The vibration device was removed from routine intramuscular Injection procedure.

Also known as: Vibration Group

Vibration Group

Shotblocker DEVICE

The protruding surface of the Shotblocker was placed on the procedure site. While applying pressure on the skin through the Shotblocker, the nurse performed with the needle through the opening in the center of the Shotblocker. During the 10-second waiting phase, the Shotblocker was kept at the procedure site with the same pressure. Then Shotblocker was removed from the skin and routine capillary intramuscular injection procedure was performed.

Also known as: Shotblocker Group

Shotblocker Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Volunteering of the child and parent to participate in the study,
• Children the ages between 5-10,
• Having intramuscular (IM) injection.

You may not qualify if:

• Communication problem,
• Children with any chronic illness,
• Taking any medication that has an analgesic effect at least 6 hours before applying.

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain; Emergencies

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Selda A ATES BESIRIK, PhD.

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selda ATES BESIRIK, PhD. Study Principal Investigator, Assist. Prof.

CONTACT

+905543683323; seldaates07@gmail.com

Selda ATES BESIRIK, PhD.

CONTACT

seldaates07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: None (Open Label)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized controlled trial. A total of three groups as 2 interventions (Vibration and ShotBlocker) and Control group (routine application)

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start: August 2, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 16, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)