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

Conditions

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.

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

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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