- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05481203
The Effect Of Distraction Methods On Fear And Anxiety In Children Before The Covid 19 Test
July 29, 2022 updated by: Hatice Uzşen, Ondokuz Mayıs University
Aim: This research will be carried out to determine the effect of distracting methods on fear and anxiety in children before the COVID test.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Inroduction: In the literature review, it has been seen that the positive effect of different nanpharmacological methods is supported to reduce pain and anxiety caused by medical procedures.
Non-pharmacological methods are classified as physical methods, cognitive behavioral methods, and environmental or emotional intervention methods.
In order to draw attention to another direction, which is among these methods; watching cartoons, inflating balloons, creating balloons by blowing foam, talking about things unrelated to the initiative, virtual reality glasses, listening to music, using kaleidoscope and distraction cards etc. is located.
The subject of the study is the application of distraction methods in reducing the pain associated with short-term medical interventions.
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Atakum
-
Samsun, Atakum, Turkey, 55250
- Ondokuz Mayis University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children who will be taken samples for Covid 19 test
- being between the ages of 5 to 10 years,
- literate
Exclusion Criteria:
- having chronic diseasesvisual
- audio, or speech impairments
- mental disorders,
- history of sedative, analgesic, or narcotic use within 24 h before admission
- inflammatory disease during admission.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: The Kaleidescope Group
Kaleidoscope Group: it and asking about the colors and shapes seen within it.
This distraction procedure started before the procedure and continued until it ended.
|
During the nasopharyngeal swab collection process, the researcher held a kaleidoscope to each child's eye, leisurely turning it and asking about the colors and shapes seen within it.
|
Experimental: The Visual Illusion Cards Group
The Visual Illusion Cards Group: Just before the nasopharyngeal swab participants were allowed to check the cards and were asked what they saw in them.
|
Just before the nasopharyngeal swab participants were allowed to check the cards andwere askedwhat they saw in them.
|
No Intervention: The Control Group
The control group received the routine nasopharyngeal swab procedure and did not receive any other nonpharmacological intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changing the anxiety in the Kaleidoscope group
Time Frame: up to 6 months
|
changing the anxiety scores of the children in the Kaleidoscope group during Covid 19 test
|
up to 6 months
|
changing the fear in the Kaleidoscope group
Time Frame: up to 6 months
|
changing the fear scores of the children in the Kaleidoscope group during Covid 19 test
|
up to 6 months
|
changing the anxiety in the Visual Illusion Cards group
Time Frame: up to 6 months
|
changing the anxiety scores of the children in the Visual Illusion Cards group during Covid 19 test
|
up to 6 months
|
changing the fear in the Visual Illusion Cards group
Time Frame: up to 6 months
|
changing thefear scores of the children in the Visual Illusion Cards group during Covid 19 test
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changing the "Child Anxiety Scale-Stateness" score
Time Frame: up to 6 months
|
The Children's Anxiety Meter (CAM) used.
It assesses children's anxiety in clinical settings and uses before medical procedures.
The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top.
Children are asked to mark how he/she feel "right now" to measure state anxiety.
Scores range from 0 to 10.
|
up to 6 months
|
changing the "Child Fear Scale" score
Time Frame: up to 6 months
|
The Child Fear Scale (CFS) used.
This one-item scale consists of five sex-neutral faces.
It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right.
The rater responds indicates the level of fear.
Scores range from 0 to 4.
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
July 1, 2022
Study Registration Dates
First Submitted
July 28, 2022
First Submitted That Met QC Criteria
July 29, 2022
First Posted (Actual)
August 1, 2022
Study Record Updates
Last Update Posted (Actual)
August 1, 2022
Last Update Submitted That Met QC Criteria
July 29, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Distraction
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
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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