search
Back to results

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

Primary Purpose

Pain, Fear, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
distraction methods
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring intramuscular injection, distraction methods, cold vibration, manuel pressure vibration, virtual reality

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gülçin Özalp Gerçeker

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Virtual Reality Group

Manual Pressure Vibration Technique Group

Cold Vibration Group

Control Group

Arm Description

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

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

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

Standart care

Outcomes

Primary Outcome Measures

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).
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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 7, 2021
Last Updated
March 7, 2023
Sponsor
Dokuz Eylul University
search

1. Study Identification

Unique Protocol Identification Number
NCT04847934
Brief Title
Effect Of Distraction Methods On Procedure-Related Fear, Anxiety, And Pain During Intramuscular Injection
Official Title
Effect Of Distraction Methods On Procedure-Related Fear, Anxiety, And Pain During Intramuscular Injection in Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 30, 2021 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Fear, Anxiety, Child, Only
Keywords
intramuscular injection, distraction methods, cold vibration, manuel pressure vibration, virtual reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm Description
watching the application by wearing virtual glasses to the child during the intramuscular injection
Arm Title
Manual Pressure Vibration Technique Group
Arm Type
Experimental
Arm Description
Application of manual pressure vibration technique to the area where the intervention will be made
Arm Title
Cold Vibration Group
Arm Type
Experimental
Arm Description
Buzzy, connecting and operating 5 cm above the area to be injected
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standart care
Intervention Type
Behavioral
Intervention Name(s)
distraction methods
Intervention Description
distraction methods
Primary Outcome Measure Information:
Title
Pain assesed by Wong-Baker FACES
Description
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).
Time Frame
procedure (during the ıntramuscular injection)
Title
Anxiety assesed by Children Anxiety Meter-State
Description
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
Time Frame
procedure (during the intramuscular injection)
Title
Fear assesed by Child Fear Scale
Description
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.
Time Frame
procedure (during the ıntramuscular injection)
Secondary Outcome Measure Information:
Title
Emotional Appearance Scale for Children
Description
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.
Time Frame
Baseline (before the intramuscular injection)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin Ö Gerçeker
Organizational Affiliation
RN, PhD, Assoc. Prof.
Official's Role
Study Director
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs