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

Primary Purpose

Anxiety, Fear

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Kaleidescope
The visual illusion cards
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring COVID-19 test, nasopharyngeal swab collection, pediatric nursing, distraction methods

Eligibility Criteria

5 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ondokuz Mayis University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

The Kaleidescope Group

The Visual Illusion Cards Group

The Control Group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 28, 2022
Last Updated
July 29, 2022
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT05481203
Brief Title
The Effect Of Distraction Methods On Fear And Anxiety In Children Before The Covid 19 Test
Official Title
The Effect Of Distraction Methods On Fear And Anxiety In Children Before The Covid 19 Test
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Fear
Keywords
COVID-19 test, nasopharyngeal swab collection, pediatric nursing, distraction methods

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This was an RCT with parallel groups conducted between March, 2022 and August, 2022 at the pediatric emergency unit of a hospital in Black Sea Region Turkey
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Kaleidescope Group
Arm Type
Experimental
Arm Description
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.
Arm Title
The Visual Illusion Cards Group
Arm Type
Experimental
Arm Description
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.
Arm Title
The Control Group
Arm Type
No Intervention
Arm Description
The control group received the routine nasopharyngeal swab procedure and did not receive any other nonpharmacological intervention
Intervention Type
Behavioral
Intervention Name(s)
The Kaleidescope
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The visual illusion cards
Intervention Description
Just before the nasopharyngeal swab participants were allowed to check the cards andwere askedwhat they saw in them.
Primary Outcome Measure Information:
Title
changing the anxiety in the Kaleidoscope group
Description
changing the anxiety scores of the children in the Kaleidoscope group during Covid 19 test
Time Frame
up to 6 months
Title
changing the fear in the Kaleidoscope group
Description
changing the fear scores of the children in the Kaleidoscope group during Covid 19 test
Time Frame
up to 6 months
Title
changing the anxiety in the Visual Illusion Cards group
Description
changing the anxiety scores of the children in the Visual Illusion Cards group during Covid 19 test
Time Frame
up to 6 months
Title
changing the fear in the Visual Illusion Cards group
Description
changing thefear scores of the children in the Visual Illusion Cards group during Covid 19 test
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
changing the "Child Anxiety Scale-Stateness" score
Description
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
Title
changing the "Child Fear Scale" score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ondokuz Mayis University
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55250
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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