Nursing CariesNCT04127097
The Effect of Watching Cartoons During Treatment on Children's Anxiety and Fear Levels
A study testing cartoon group in people with Nursing Caries and Anxiety, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: The study was carried out in a randomized controlled manner to determine the effect of the watching cartoons on the fear and anxiety levels of children during treatment. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Anxiety, Fear
- What is being tested?
- cartoon group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2019to 1 Nov 2019
- 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
- being healthy
- ability to express himself/herself verbally
- having no visual or auditory problems
Who cannot join
- mental disease
- neurological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Batman obstetrics and pediatric hospital
Batman, 72060
About this study
Objective: The study was carried out in a randomized controlled manner to determine the effect of the watching cartoons on the fear and anxiety levels of children during treatment.
Method: The population of the study consisted of children aged 5-10 years who were brought to a state hospital in a southeastern province for blood collection. A total of 92 children, 43 of whom were in the cartoon group and 49 of which were in the control group, were included in the study. Research findings; Data Form was obtained by using Child Anxiety Scale and Child Fear Scale. The children in the cartoon group were shown the cartoons they wanted during the treatment. Anxiety and fear levels before and during the blood collection were evaluated in the cartoon and control groups. The anxiety level of the children was evaluated according to their own expressions, and the level of fear was evaluated independently according to both the children's own statements and the observers' statements.
- Conditions
- Nursing Caries, Anxiety, Fear
- Being tested
- cartoon group
- Keywords
- anxiety, fear, nursing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cartoon groupOther
The children in the groups were distracted by watching cartoon 2 minutes before treatment, until the process was over
| Study group | Role | What they receive |
|---|---|---|
| cartoon group | Experimental | Not described Receives: Other: cartoon group |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children Fear Scale
The scale is used to evaluate the anxiety level of 4-10 year-old children. Five images of cartoon faces are used in the scale. Anxiety level is evaluated with numbers between "0" and "4". While "0" point refers to "no anxiety", "4" points refer to "severe anxiety"
Measured: 1 minute
Children Anxiety Scale
it is similar to a thermometer with a bulb at the bottom and horizontal lines at upwardly spaced intervals. In the scale for children aged four to ten years, the child is asked to indicate that he / she feels "now için to measure State anxiety. Score can vary from 0 to 10
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start30 Sep 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Koc Ozkan, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127097
- Sponsor's protocol ID
- 2019/6-2
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Watching Cartoons During Treatment on Children's Anxiety and Fear Levels
- ClinicalTrials.gov ID
- NCT04127097
- Acronym / sponsor ID
- 2019/6-2
- Conditions
- Nursing Caries, Anxiety, Fear
- Keywords
- anxiety, fear, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 15 Oct 2019 (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.
Objective: The study was carried out in a randomized controlled manner to determine the effect of the watching cartoons on the fear and anxiety levels of children during treatment.
Method: The population of the study consisted of children aged 5-10 years who were brought to a state hospital in a southeastern province for blood collection. A total of 92 children, 43 of whom were in the cartoon group and 49 of which were in the control group, were included in the study. Research findings; Data Form was obtained by using Child Anxiety Scale and Child Fear Scale. The children in the cartoon group were shown the cartoons they wanted during the treatment. Anxiety and fear levels before and during the blood collection were evaluated in the cartoon and control groups. The anxiety level of the children was evaluated according to their own expressions, and the level of fear was evaluated independently according to both the children's own statements and the observers' statements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cartoon group | Experimental | Other: cartoon group |
| control group | No intervention | – |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being healthy
- ability to express himself/herself verbally
- having no visual or auditory problems
Key exclusion criteria (2 listed)
- mental disease
- neurological disease
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 |
|---|---|---|
| cartoon groupThe children in the groups were distracted by watching cartoon 2 minutes before treatment, until the process was over | Other | cartoon group |
Primary outcome
Children Fear Scale
Time frame: 1 minute
The scale is used to evaluate the anxiety level of 4-10 year-old children. Five images of cartoon faces are used in the scale. Anxiety level is evaluated with numbers between "0" and "4". While "0" point refers to "no anxiety", "4" points refer to "severe anxiety"
Children Anxiety Scale
Time frame: 1 minute
it is similar to a thermometer with a bulb at the bottom and horizontal lines at upwardly spaced intervals. In the scale for children aged four to ten years, the child is asked to indicate that he / she feels "now için to measure State anxiety. Score can vary from 0 to 10
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 14 Oct 2020.
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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 cartoon group in people with Nursing Caries and Anxiety, run by Adiyaman University Research Hospital 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 2 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 14 Oct 2020. 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?
Children Fear Scale (time frame: 1 minute). The study lists 2 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 14 Oct 2020.