CoronavirusNCT05265390
The Effect of Video Information on Anxiety in Adolescents Having rRT-PCR Test During Corona Virus Pandemic
A study testing Adolescents watching an informational video in people with Coronavirus, run by Mersin University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Coronavirus
- What is being tested?
- Adolescents watching an informational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2022to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin Toros Public Hospital
Mersin, Akdeniz, 33343
About this study
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
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.
Read the 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.
- Conditions
- Coronavirus
- Being tested
- Adolescents watching an informational video
- Keywords
- Coronavirus, Polymerase Chain Reaction, Adolescent, Anxiety, Information video
- Medical subject headings
- Coronavirus Infections, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescents watching an informational videoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Anxiety level of the group watching the informational video Receives: Other: Adolescents watching an informational video |
| control group | No intervention | Anxiety level of control group adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 minutes after giving a PCR test sample, the control group's State Anxiety Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start5 Feb 2022
- Primary completion31 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zühal Artuvan, Mersin University
- Investigators
- Zühal Artuvan, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265390
- Status last verified
- Jul 2023
- First submitted
- 2 Feb 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05265390
- Conditions
- Coronavirus
- Keywords
- Coronavirus, Polymerase Chain Reaction, Adolescent, Anxiety, Information video
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Adolescents watching an informational videoAnxiety level of the group watching the informational video |
| control group | No intervention | –Anxiety level of control group adolescents |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adolescents watching an informational videoIn 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. | Other | intervention group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zühal Artuvan principal investigator
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescents watching an informational video in people with Coronavirus, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.