Effect Of Distraction Methods On Procedure-Related Fear, Anxiety, And Pain During Intramuscular Injection

NCT04847934 | Completed DMC

• 1 other identifier: 5856-GOA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Buzzy, shot-blocker, distraction cards, and balloon blowing can reduce fear and pain during the intramuscular intervention in the pediatric emergency service unit. This study aimed to evaluate the effect of virtual reality, manual pressure vibration technique, and cold vibration device application on procedure-related pain, fear, and anxiety during intramuscular antibiotics in children aged 5-12 years in the pediatric emergency department.

Conditions

Pain; Fear; Anxiety; Child, Only

Keywords

intramuscular injection; distraction methods; cold vibration; manuel pressure vibration; virtual reality

Outcome Measures

Primary Outcomes (3)

• Pain assesed by Wong-Baker FACES

  Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).

  procedure (during the ıntramuscular injection)

• Anxiety assesed by Children Anxiety Meter-State

  The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety

  procedure (during the intramuscular injection)

• Fear assesed by Child Fear Scale

  The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear. It can be used during the procedure for children aged 5-10 years.

  procedure (during the ıntramuscular injection)

Secondary Outcomes (1)

• Emotional Appearance Scale for Children

  Baseline (before the intramuscular injection)

Study Arms (4)

Virtual Reality Group

EXPERIMENTAL

watching the application by wearing virtual glasses to the child during the intramuscular injection

Behavioral: distraction methods

Manual Pressure Vibration Technique Group

EXPERIMENTAL

Application of manual pressure vibration technique to the area where the intervention will be made

Behavioral: distraction methods

Cold Vibration Group

EXPERIMENTAL

Buzzy, connecting and operating 5 cm above the area to be injected

Behavioral: distraction methods

Control Group

NO INTERVENTION

Standart care

Interventions

distraction methods BEHAVIORAL

distraction methods

Cold Vibration Group; Manual Pressure Vibration Technique Group; Virtual Reality Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children are between the ages of 5-12
• Intramuscular antibiotics (penicillin, ceftriaxone, amikacin etc.) to be administered
• The intervention will be applied from the gluteal region
• The child agrees to voluntarily participate in the study.
• Parents agree to voluntarily participate in the study
• Obtaining consent form from the child and parent

You may not qualify if:

• child with a physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
• child with sedative or analgesic medication.
• child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• Gulduran E, Ozalp Gerceker G. Effect of Distracting Methods on Procedure-Related Fear, Anxiety, and Pain During Intramuscular Injection: A Randomized Controlled Trial. J Emerg Nurs. 2026 Jan;52(1):127-142. doi: 10.1016/j.jen.2025.08.003. Epub 2025 Sep 9.

  PMID: 40923961 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Gülçin Ö Gerçeker

  RN, PhD, Assoc. Prof.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dokuz Eylul University

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 19, 2021
• Study Start: January 30, 2021
• Primary Completion: December 29, 2022
• Study Completion: December 30, 2022
• Last Updated: March 8, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)