NCT05481203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 28, 2022

Last Update Submit

July 29, 2022

Conditions

Keywords

COVID-19 testnasopharyngeal swab collectionpediatric nursingdistraction methods

Outcome Measures

Primary Outcomes (4)

  • changing the anxiety in the Kaleidoscope group

    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

    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

    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

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

    up to 6 months

Secondary Outcomes (2)

  • changing the "Child Anxiety Scale-Stateness" score

    up to 6 months

  • changing the "Child Fear Scale" score

    up to 6 months

Study Arms (3)

The Kaleidescope Group

EXPERIMENTAL

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

The Visual Illusion Cards Group

EXPERIMENTAL

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

The Control Group

NO INTERVENTION

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

Interventions

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.

The Kaleidescope Group

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

The Visual Illusion Cards Group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 1, 2022

Study Start

March 1, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations