- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05434832
Effects of Virtual Reality, External Cold and Vibration to Children During IM Injection on Pain, Fear and Anxiety
The Effect of Virtual Reality and Local Cold Application-Vibration Methods on Reducing Anxiety, Fear and Pain Developed During Intramuscular Injection in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Akdeniz University
-
Antalya, Akdeniz University, Turkey, 07058
- Aysegul ISLER DALGIC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The child is between the ages of 5 and 10
Having intramuscular (IM) injection therapy
Absence of Audio-Visual-Sensation loss problem
No communication problem
Absence of mental retardation
Absence of a disease causing chronic pain
No history of fainting during injection
Not taking any analgesic medication in the last 4 hours
Exclusion Criteria:
Failure of IM application at one time
The child in the virtual reality application group removes the virtual reality glasses during the IM injection.
The child in the group receiving Buzzy application removes the Buzzy device during IM injection.
Not wanting to fill the scales after the application
Diagnosis or suspicion of COVID-19 (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat, contact with a COVID-19 positive person)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual Reality Group
watching the cartoon by wearing virtual reality glass to the child during the intramuscular injection
|
Distraction method
|
Experimental: Local cold-vibration Group
The local cold-vibration device is placed 5 cm above the area to be injected
|
Distraction method
|
No Intervention: Control Group
standart care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety assesed by Children's State Anxiety
Time Frame: Before the intramuscular injection
|
The Children's State Anxiety (CAS-S).
The CAS-S 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
|
Before the intramuscular injection
|
Anxiety assesed by Children's State Anxiety
Time Frame: Within the first 5 minutes after the intramuscular injection
|
The Children's State Anxiety (CAS-S).
The CAS-S 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
|
Within the first 5 minutes after the intramuscular injection
|
Fear assesed by Child Fear Scale
Time Frame: Before the intramuscular injection
|
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.
|
Before the intramuscular injection
|
Fear assesed by Child Fear Scale
Time Frame: Within the first 5 minutes after the intramuscular injection
|
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.
|
Within the first 5 minutes after the intramuscular injection
|
Pain assesed by Wong-Baker FACES
Time Frame: Before the intramuscular injection
|
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).
|
Before the intramuscular injection
|
Pain assesed by Wong-Baker FACES
Time Frame: Within the first 5 minutes after the intramuscular injection
|
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).
|
Within the first 5 minutes after the intramuscular injection
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aysegul ISLER DALGIC, Professor, Akdeniz University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/920
- 5207 (AKD Scientific Research Projects Coordination Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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