Coronavirus Clinical Trial
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
NCT number | NCT05265390 |
Other study ID # | |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 5, 2022 |
Est. completion date | June 1, 2022 |
Verified date | July 2023 |
Source | Mersin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 272 |
Est. completion date | June 1, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Turkey | Mersin Toros Public Hospital | Mersin | Akdeniz |
Lead Sponsor | Collaborator |
---|---|
Mersin University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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