AnxietyNCT05481203
The Effect Of Distraction Methods On Fear And Anxiety In Children Before The Covid 19 Test
A study testing The Kaleidescope and The visual illusion cards in people with Anxiety and Fear, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This research will be carried out to determine the effect of distracting methods on fear and anxiety in children before the COVID test. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- What is being tested?
- The Kaleidescope and The visual illusion cards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Jul 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children who will be taken samples for Covid 19 test
- being between the ages of 5 to 10 years,
- literate
Who cannot join
- having chronic diseasesvisual
- audio, or speech impairments
- mental disorders,
- history of sedative, analgesic, or narcotic use within 24 h before admission
- inflammatory disease during admission.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55250
About this study
Aim: This research will be carried out to determine the effect of distracting methods on fear and anxiety in children before the COVID test.
Read the detailed description
Inroduction: In the literature review, it has been seen that the positive effect of different nanpharmacological methods is supported to reduce pain and anxiety caused by medical procedures. Non-pharmacological methods are classified as physical methods, cognitive behavioral methods, and environmental or emotional intervention methods. In order to draw attention to another direction, which is among these methods; watching cartoons, inflating balloons, creating balloons by blowing foam, talking about things unrelated to the initiative, virtual reality glasses, listening to music, using kaleidoscope and distraction cards etc. is located. The subject of the study is the application of distraction methods in reducing the pain associated with short-term medical interventions.
- Being tested
- The Kaleidescope, The visual illusion cards
- Keywords
- COVID-19 test, nasopharyngeal swab collection, pediatric nursing, distraction methods
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The KaleidescopeBehavioural
During the nasopharyngeal swab collection process, the researcher held a kaleidoscope to each child's eye, leisurely turning it and asking about the colors and shapes seen within it.
The visual illusion cardsBehavioural
Just before the nasopharyngeal swab participants were allowed to check the cards andwere askedwhat they saw in them.
| Study group | Role | What they receive |
|---|---|---|
| The Kaleidescope Group | Experimental | Kaleidoscope Group: it and asking about the colors and shapes seen within it. This distraction procedure started before the procedure and continued until it ended. Receives: Behavioral: The Kaleidescope |
| The Visual Illusion Cards Group | Experimental | The Visual Illusion Cards Group: Just before the nasopharyngeal swab participants were allowed to check the cards and were asked what they saw in them. Receives: Behavioral: The visual illusion cards |
| The Control Group | No intervention | The control group received the routine nasopharyngeal swab procedure and did not receive any other nonpharmacological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
changing the anxiety in the Kaleidoscope group
changing the anxiety scores of the children in the Kaleidoscope group during Covid 19 test
Measured: up to 6 months
changing the fear in the Kaleidoscope group
changing the fear scores of the children in the Kaleidoscope group during Covid 19 test
Measured: up to 6 months
changing the anxiety in the Visual Illusion Cards group
changing the anxiety scores of the children in the Visual Illusion Cards group during Covid 19 test
Measured: up to 6 months
changing the fear in the Visual Illusion Cards group
changing thefear scores of the children in the Visual Illusion Cards group during Covid 19 test
Measured: up to 6 months
Secondary outcomes (2)
changing the "Child Anxiety Scale-Stateness" score
The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety. Scores range from 0 to 10.
Measured: up to 6 months
changing the "Child Fear Scale" score
The Child Fear Scale (CFS) used. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. Scores range from 0 to 4.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was an RCT with parallel groups conducted between March, 2022 and August, 2022 at the pediatric emergency unit of a hospital in Black Sea Region Turkey
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Uzşen, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481203
- Sponsor's protocol ID
- Distraction
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- 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 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Distraction Methods On Fear And Anxiety In Children Before The Covid 19 Test
- ClinicalTrials.gov ID
- NCT05481203
- Acronym / sponsor ID
- Distraction
- Keywords
- COVID-19 test, nasopharyngeal swab collection, pediatric nursing, distraction methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 1 Aug 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.
Aim: This research will be carried out to determine the effect of distracting methods on fear and anxiety in children before the COVID test.
Detailed description
Inroduction: In the literature review, it has been seen that the positive effect of different nanpharmacological methods is supported to reduce pain and anxiety caused by medical procedures. Non-pharmacological methods are classified as physical methods, cognitive behavioral methods, and environmental or emotional intervention methods. In order to draw attention to another direction, which is among these methods; watching cartoons, inflating balloons, creating balloons by blowing foam, talking about things unrelated to the initiative, virtual reality glasses, listening to music, using kaleidoscope and distraction cards etc. is located. The subject of the study is the application of distraction methods in reducing the pain associated with short-term medical interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This was an RCT with parallel groups conducted between March, 2022 and August, 2022 at the pediatric emergency unit of a hospital in Black Sea Region Turkey
| Arm | Type | Receives |
|---|---|---|
| The Kaleidescope Group | Experimental | Behavioral: The KaleidescopeKaleidoscope Group: it and asking about the colors and shapes seen within it. This distraction procedure started before the procedure and continued until it ended. |
| The Visual Illusion Cards Group | Experimental | Behavioral: The visual illusion cardsThe Visual Illusion Cards Group: Just before the nasopharyngeal swab participants were allowed to check the cards and were asked what they saw in them. |
| The Control Group | No intervention | –The control group received the routine nasopharyngeal swab procedure and did not receive any other nonpharmacological intervention |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children who will be taken samples for Covid 19 test
- being between the ages of 5 to 10 years,
- literate
Key exclusion criteria (5 listed)
- having chronic diseasesvisual
- audio, or speech impairments
- mental disorders,
- history of sedative, analgesic, or narcotic use within 24 h before admission
- inflammatory disease during admission.
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 |
|---|---|---|
| The KaleidescopeDuring the nasopharyngeal swab collection process, the researcher held a kaleidoscope to each child's eye, leisurely turning it and asking about the colors and shapes seen within it. | Behavioural | The Kaleidescope Group |
| The visual illusion cardsJust before the nasopharyngeal swab participants were allowed to check the cards andwere askedwhat they saw in them. | Behavioural | The Visual Illusion Cards Group |
Primary outcome
changing the anxiety in the Kaleidoscope group
Time frame: up to 6 months
changing the anxiety scores of the children in the Kaleidoscope group during Covid 19 test
changing the fear in the Kaleidoscope group
Time frame: up to 6 months
changing the fear scores of the children in the Kaleidoscope group during Covid 19 test
changing the anxiety in the Visual Illusion Cards group
Time frame: up to 6 months
changing the anxiety scores of the children in the Visual Illusion Cards group during Covid 19 test
changing the fear in the Visual Illusion Cards group
Time frame: up to 6 months
changing thefear scores of the children in the Visual Illusion Cards group during Covid 19 test
2 secondary outcomes
changing the "Child Anxiety Scale-Stateness" score
Time frame: up to 6 months
changing the "Child Fear Scale" score
Time frame: up to 6 months
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 1 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Kaleidescope and The visual illusion cards in people with Anxiety and Fear, run by Ondokuz Mayıs 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 3 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 1 Aug 2022. 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?
changing the anxiety in the Kaleidoscope group (time frame: up to 6 months). The study lists 4 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 1 Aug 2022.