NCT05265390

Brief Summary

The Polymerase Chain Reaction (rRT-PCR) test is still the gold standard in the diagnosis of coronavirus disease. Health workers apply this procedure in a closed area, wearing personal protective equipment. Adolescents cannot be informed about the invasive procedure and it is difficult to communicate with them. Before the procedure, the effect on anxiety will be investigated by watching an informative video (containing information such as the materials used in the procedure, how long the procedure will take, how the sample will be taken, why healthcare workers wear personal protective equipment) prepared according to the developmental characteristics of the adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

February 5, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

February 2, 2022

Last Update Submit

July 20, 2023

Conditions

Keywords

CoronavirusPolymerase Chain ReactionAdolescentAnxietyInformation video

Outcome Measures

Primary Outcomes (8)

  • State Anxiety Inventory Score Form - 1 (STAI FORM -1)

    State Anxiety Inventory Score Form - 1. The lowest total score is 20 and the highest total score is 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    20 minutes before giving a PCR test sample, the intervention group's State Anxiety Score

  • Trait Anxiety Score Form - 2 (STAI FORM -2)

    Trait Anxiety Score Form - 2. A total score of 0-19 obtained from the scales indicates no anxiety, a total score of 20-39 indicates mild anxiety, a total score of 40-59 indicates moderate anxiety, and a total score of 60-79 indicates severe anxiety.

    20 minutes before giving a PCR test sample, the intervention group's Trait Anxiety Score

  • Coronavirus Anxiety Scale (CAS)

    Coronavirus Anxiety Scale - A total score of 9 or more indicates coronavirus-related anxiety.

    20 minutes before giving a PCR test sample, the intervention group's Coronavirus Anxiety Scale Score

  • State Anxiety Inventory Score Form - 1 (STAI FORM -1)

    State Anxiety Inventory Score Form - 1. The lowest total score is 20 and the highest total score is 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    20 minutes before giving a PCR test sample, the control group's State Anxiety Score

  • Trait Anxiety Score Form - 2 (STAI FORM -2)

    Trait Anxiety Score Form - 2. A total score of 0-19 obtained from the scales indicates no anxiety, a total score of 20-39 indicates mild anxiety, a total score of 40-59 indicates moderate anxiety, and a total score of 60-79 indicates severe anxiety.

    20 minutes before giving a PCR test sample, the control group's Trait Anxiety Score

  • Coronavirus Anxiety Scale (CAS)

    Coronavirus Anxiety Scale - A total score of 9 or more indicates coronavirus-related anxiety.

    20 minutes before giving a PCR test sample, the control group's Coronavirus Anxiety Scale Score

  • State Anxiety Inventory Score Form - 1 (STAI FORM -1)

    State Anxiety Inventory Score Form - 1. The lowest total score is 20 and the highest total score is 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    1 minutes after giving a PCR test sample, the intervention group's State Anxiety Score

  • State Anxiety Inventory Score Form - 1 (STAI FORM -1)

    State Anxiety Inventory Score Form - 1. The lowest total score is 20 and the highest total score is 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    1 minutes after giving a PCR test sample, the control group's State Anxiety Score

Study Arms (2)

intervention group

EXPERIMENTAL

Anxiety level of the group watching the informational video

Other: Adolescents watching an informational video

control group

NO INTERVENTION

Anxiety level of control group adolescents

Interventions

In the information video; The materials used during the PCR test, how long the process will take, how the sample will be taken, why healthcare professionals wear personal protective equipment, and what adolescents should do are included.

intervention group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Applying to State Hospital for a PCR test
  • Being literate in Turkish
  • Not having a hearing or visual impairment, not having a mental disability.
  • Not having had a previous PCR test sample taken
  • To be in good general condition (clinically)
  • Signing the informed consent form (child and parent)

You may not qualify if:

  • Being illiterate in Turkish
  • Hearing or visual impairment, mental disability
  • Previous PCR test sample taken
  • Absence of parents next to the adolescent
  • Those who did not sign the informed consent form (child and parent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin Toros Public Hospital

Mersin, Akdeniz, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronavirus InfectionsAnxiety Disorders

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsMental Disorders

Study Officials

  • Zühal Artuvan

    Mersin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Nurse

Study Record Dates

First Submitted

February 2, 2022

First Posted

March 3, 2022

Study Start

February 5, 2022

Primary Completion

May 31, 2022

Study Completion

June 1, 2022

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations