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The Effect of Video Information on Anxiety in Adolescents Having rRT-PCR Test During Corona Virus Pandemic

Primary Purpose

Coronavirus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Adolescents watching an informational video
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronavirus focused on measuring Coronavirus, Polymerase Chain Reaction, Adolescent, Anxiety, Information video

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Sites / Locations

  • Mersin Toros Public Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

Anxiety level of the group watching the informational video

Anxiety level of control group adolescents

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2022
Last Updated
July 20, 2023
Sponsor
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT05265390
Brief Title
The Effect of Video Information on Anxiety in Adolescents Having rRT-PCR Test During Corona Virus Pandemic
Official Title
The Effect of Video Informing Adolescents Having Polymerase Chain Reaction (rRT-PCR) Test on Anxiety During the Coronavirus (COVID-19) Pandemic: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.
Detailed Description
In the coronavirus pandemic, PCR testing is still the gold standard in the diagnosis of the disease. PCR with the right method can increase the sensitivity of the test. Adolescents' anxiety and anxiety levels may increase during invasive procedures such as PCR testing. In addition, in this process, factors such as the uncertainty created by the pandemic, disruption of routines, loss of school and peer social ties, and fear of getting sick bring along many mental disorders. The fact that the tests and treatments for the disease are new and that they are not informed about the procedures to be done cause the anxiety levels of the adolescents to increase. Nurses who treat adolescents with care and personal protective equipment may not be able to communicate verbally, sensorially, eye-to-eye with adolescents, and may have difficulty in conveying their voices and emotions. Likewise, by wearing a mask, it prevents nurses from observing their reactions to the hospital environment and procedures. Video education is one of the most effective ways for nurses to fulfill their educational roles during the epidemic when communication is limited. For this reason, it is very important to inform before the PCR sample collection process with a video prepared in accordance with the developmental stages of the adolescents. The aim of this study is to investigate the effect of the video that adolescents will watch before the procedure on their anxiety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus
Keywords
Coronavirus, Polymerase Chain Reaction, Adolescent, Anxiety, Information video

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Anxiety level of the group watching the informational video
Arm Title
control group
Arm Type
No Intervention
Arm Description
Anxiety level of control group adolescents
Intervention Type
Other
Intervention Name(s)
Adolescents watching an informational video
Intervention Description
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.
Primary Outcome Measure Information:
Title
State Anxiety Inventory Score Form - 1 (STAI FORM -1)
Description
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.
Time Frame
20 minutes before giving a PCR test sample, the intervention group's State Anxiety Score
Title
Trait Anxiety Score Form - 2 (STAI FORM -2)
Description
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.
Time Frame
20 minutes before giving a PCR test sample, the intervention group's Trait Anxiety Score
Title
Coronavirus Anxiety Scale (CAS)
Description
Coronavirus Anxiety Scale - A total score of 9 or more indicates coronavirus-related anxiety.
Time Frame
20 minutes before giving a PCR test sample, the intervention group's Coronavirus Anxiety Scale Score
Title
State Anxiety Inventory Score Form - 1 (STAI FORM -1)
Description
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.
Time Frame
20 minutes before giving a PCR test sample, the control group's State Anxiety Score
Title
Trait Anxiety Score Form - 2 (STAI FORM -2)
Description
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.
Time Frame
20 minutes before giving a PCR test sample, the control group's Trait Anxiety Score
Title
Coronavirus Anxiety Scale (CAS)
Description
Coronavirus Anxiety Scale - A total score of 9 or more indicates coronavirus-related anxiety.
Time Frame
20 minutes before giving a PCR test sample, the control group's Coronavirus Anxiety Scale Score
Title
State Anxiety Inventory Score Form - 1 (STAI FORM -1)
Description
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.
Time Frame
1 minutes after giving a PCR test sample, the intervention group's State Anxiety Score
Title
State Anxiety Inventory Score Form - 1 (STAI FORM -1)
Description
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.
Time Frame
1 minutes after giving a PCR test sample, the control group's State Anxiety Score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zühal Artuvan
Organizational Affiliation
Mersin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mersin Toros Public Hospital
City
Mersin
State/Province
Akdeniz
ZIP/Postal Code
33343
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Video Information on Anxiety in Adolescents Having rRT-PCR Test During Corona Virus Pandemic

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