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CompletedNCT05481203Updated Aug 1, 2022

The Effect Of Distraction Methods On Fear And Anxiety In Children Before The Covid 19 Test

An interventional study of The Kaleidescope and The visual illusion cards in Anxiety and Fear, sponsored by Ondokuz Mayıs University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-01.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2022, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
5 Years to 10 Years
Sex
All
01

Study summary

Aim: This research will be carried out to determine the effect of distracting methods on fear and anxiety in children before the COVID test.

Read the 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.

02

Conditions studied

  • Anxiety
  • Fear

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Keywords

  • COVID-19 test
  • nasopharyngeal swab collection
  • pediatric nursing
  • distraction methods
03

In context

Anxiety Disorders

5,073 studies on the registry are indexed under Anxiety Disorders; 1,406 are open to participants now.

This study's enrollment of 114 is above the median of 80 across 4,341 interventional studies indexed under Anxiety Disorders.

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Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 275 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • children who will be taken samples for Covid 19 test
  • being between the ages of 5 to 10 years,
  • literate

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
114 participants (actual)

Study arms

  • 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.

    Behavioral: The Kaleidescope

  • 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.

    Behavioral: The visual illusion cards

  • No intervention
    The Control Group

    The control group received the routine nasopharyngeal swab procedure and did not receive any other nonpharmacological intervention

Interventions

  • BehavioralThe Kaleidescope

    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.

  • BehavioralThe visual illusion cards

    Just before the nasopharyngeal swab participants were allowed to check the cards andwere askedwhat they saw in them.

06

What researchers measure

Primary outcomes

  1. changing the anxiety in the Kaleidoscope group

    changing the anxiety scores of the children in the Kaleidoscope group during Covid 19 test

    Time frame: up to 6 months

  2. changing the fear in the Kaleidoscope group

    changing the fear scores of the children in the Kaleidoscope group during Covid 19 test

    Time frame: up to 6 months

  3. changing the anxiety in the Visual Illusion Cards group

    changing the anxiety scores of the children in the Visual Illusion Cards group during Covid 19 test

    Time frame: up to 6 months

  4. changing the fear in the Visual Illusion Cards group

    changing thefear scores of the children in the Visual Illusion Cards group during Covid 19 test

    Time frame: up to 6 months

Secondary outcomes

  1. changing the "Child Anxiety Scale-Stateness" score

    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.

    Time frame: up to 6 months

  2. changing the "Child Fear Scale" score

    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.

    Time frame: up to 6 months

07

Study locations

1 site
  • Ondokuz Mayis University
    Samsun, Atakum 55250, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05481203
Responsible party
Hatice Uzşen (Principal Investigator, Ondokuz Mayıs University) — Principal investigator
First posted
Aug 1, 2022
Start date
Mar 1, 2022
Primary completion
Jun 1, 2022
Completion
Jul 1, 2022
Last update
Aug 1, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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