Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2023
Source Mersin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Adolescents watching an 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.

Locations

Country Name City State
Turkey Mersin Toros Public Hospital Mersin Akdeniz

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05065827 - Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
Recruiting NCT05359770 - Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19 N/A
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Not yet recruiting NCT06025812 - Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) N/A
Recruiting NCT05289115 - Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS N/A
Completed NCT04779138 - Increasing Vaccine Uptake in Underresourced Public Housing Areas N/A
Completed NCT04953078 - A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19 Phase 1
Not yet recruiting NCT05868239 - Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study N/A
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A
Completed NCT04818164 - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04572399 - UVA Light Device to Treat COVID-19 N/A
Recruiting NCT04610567 - Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19) Phase 1/Phase 2
Recruiting NCT04772170 - Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Recruiting NCT04581954 - Inflammatory Signal Inhibitors for COVID-19 (MATIS) Phase 1/Phase 2
Completed NCT04405934 - COG-UK Project Hospital-Onset COVID-19 Infections Study N/A
Enrolling by invitation NCT04484025 - SPI-1005 Treatment in Moderate COVID-19 Patients Phase 2
Completed NCT05572840 - Wear Your Mask, Wash Your Hands, Don't Get COVID-19 N/A
Withdrawn NCT04838847 - A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19 Phase 3
Completed NCT04556149 - imPulseā„¢ Una Full-spectrum, Over Clothing E-stethoscope