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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anxiety; Fear; Child, Only
• Intervention / Treatment: Behavioral: distraction methods

Detailed Description

Study Hypothesis The pain, fear, and anxiety scores of the children who watch videos with virtual reality glasses during the intramuscular intervention are lower than the other groups.

The pain, fear, and anxiety scores of children who were applied manual pressure vibration technique during the intramuscular intervention are lower than the other groups.

The pain, fear, and anxiety scores of the children who were applied cold vibration (Buzzy) during the intramuscular intervention were lower than the other groups.

The emotional appearance scores of the children in groups before the procedure affect the pain, fear, and anxiety they experience.

The group with children affects the vital signs before and after the distraction technique.

Methods Study Design and Sample It was planned to include children between the ages of 5-12 who will be administered intramuscular antibiotics in the Dokuz Eylül University Pediatric Emergency Service. It is planned to include patients selected by the stratified randomization method in accordance with the sampling criteria.

Randomization Children will allocate by the stratified randomization; gender, age, and antibiotics type. Randomization was performed with a computerized random-number generator.

Socio-Demographic Data Collection and Procedure Follow-up Form: It includes "age, gender, the reason for admitting to the emergency unit, the last painful intervention and date, the name of the antibiotic administered, and the accompanying parent". At the same time, the duration and vital signs of the interventions applied to the child will be recorded.

Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).

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 response indicates the level of fear. It can be used during the procedure for children aged 5-10 years.

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.

Emotional Appearance Scale for Children: This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'.

Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors.

Data collection process Each patient included in the study will be taken to the bed where the intervention will be made and monitored, pulse, respiration, and blood pressure will be measured. The child will be evaluated by the nurse before the procedure with the Emotional Appearance Scale for Children (0. Min).

In the virtual glasses group, the video will be started by wearing virtual glasses.

The manual pressure vibration technique will be applied for 15 seconds. In the cold vibration group, Arı Buzzy will be connected 5 cm above the IM intervention area and applied for 15 seconds.

The hour/minute applied by the IM intervention will be recorded. When he enters the vascular access, he will give information to the child by saying "now it will be over, I am pressing it with cotton". The patient's pulse, respiration, blood pressure will be measured again (minutes will be recorded). Pulse, respiration, and blood pressure will be re-evaluated at the 5th minute of the beginning of the procedure. At the 5th minute of the procedure, the child will be asked to evaluate the most painful moment he feels during the procedure with the Facial Expressions Rating Scale. The child will be given the Child Fear Scale (CAS) and the Child Anxiety Scale-Statefulness (CAS-D) to evaluate how anxious and afraid he or she is during the procedure. You will be asked to mark it with a pencil.

Ethics Ethical approval was received from the Non-Invasive Clinical Studies Ethics Committee of the University where the research was conducted (5856GOA 2021). The researcher informed about the aim of the study and obtained written consent forms from children and parents.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gülçin Özalp Gerçeker, pHD; Phone Number: 05306411368; Email: gulcinozalp@gmail.com
• Study Contact Backup: Name: Elfidan Gülduran; Phone Number: 05306411368; Email: elfidan.gulduran@gmail.com

Study Locations

• Turkey
  • İzmir, Turkey, 35100
    • Recruiting
    • Gülçin Özalp Gerçeker
    • Contact: Gülçin Ö Gerçeker; Phone Number: 05306411368; Email: gulcinozalp@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; watching the application by wearing virtual glasses to the child during the intramuscular injection	Behavioral: distraction methods; distraction methods
Experimental: Manual Pressure Vibration Technique Group; Application of manual pressure vibration technique to the area where the intervention will be made	Behavioral: distraction methods; distraction methods
Experimental: Cold Vibration Group; Buzzy, connecting and operating 5 cm above the area to be injected	Behavioral: distraction methods; distraction methods
No Intervention: Control Group; Standart care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Appearance Scale for Children	This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors.	Baseline (before the intramuscular injection)

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Study Director: Gülçin Ö Gerçeker, RN, PhD, Assoc. Prof.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2021
• Primary Completion (Anticipated): December 29, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: intramuscular injection; virtual reality; distraction methods; cold vibration; manuel pressure vibration
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 5856-GOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No