- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05265390
The Effect of Video Information on Anxiety in Adolescents Having rRT-PCR Test During Corona Virus Pandemic
July 20, 2023 updated by: Zühal Artuvan, Mersin University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
272
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
-
-
Akdeniz
-
Mersin, Akdeniz, Turkey, 33343
- Mersin Toros Public Hospital
-
-
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
8 years to 14 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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)
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
Anxiety level of the group watching the informational video
|
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.
|
|
No Intervention: control group
Anxiety level of control group adolescents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Inventory Score Form - 1 (STAI FORM -1)
Time Frame: 20 minutes before giving a PCR test sample, the intervention group's State Anxiety Score
|
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)
Time Frame: 20 minutes before giving a PCR test sample, the intervention group's Trait Anxiety Score
|
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)
Time Frame: 20 minutes before giving a PCR test sample, the intervention group's Coronavirus Anxiety Scale Score
|
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)
Time Frame: 20 minutes before giving a PCR test sample, the control group's State Anxiety Score
|
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)
Time Frame: 20 minutes before giving a PCR test sample, the control group's Trait Anxiety Score
|
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)
Time Frame: 20 minutes before giving a PCR test sample, the control group's Coronavirus Anxiety Scale Score
|
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)
Time Frame: 1 minutes after giving a PCR test sample, the intervention group's State Anxiety Score
|
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)
Time Frame: 1 minutes after giving a PCR test sample, the control group's State Anxiety Score
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zühal Artuvan, Mersin University
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)
February 5, 2022
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
February 2, 2022
First Submitted That Met QC Criteria
February 22, 2022
First Posted (Actual)
March 3, 2022
Study Record Updates
Last Update Posted (Estimated)
July 24, 2023
Last Update Submitted That Met QC Criteria
July 20, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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