AnxietyNCT04334733
The Impact of Preprocedural Animation About Echocardiography Display and Kaleidoscope Display on Anxiety in Children
A study testing Cartoon group, Kaleidoscope group and Cartoon+Kaleidoscope group in people with Anxiety and Child, Only, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The study was conducted for the purpose of determining the effect of making children aged 5 to 12 years watch a cartoon about echocardiography (ECO) procedure before the procedure and kaleidoscope during the procedure on their anxiety. Material and Method: It is a randomized controlled study. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Child, Only, Echocardiography
- What is being tested?
- Cartoon group, Kaleidoscope group and Cartoon+Kaleidoscope group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2018to 25 Dec 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being healthy
- ability to express himself/herself verbally
- no sedation taken in the last eight hours
- having no visual or auditory problems
- Ecocardiography process is to be held for the first time
Who cannot join
- chronic disease
- mental disease
- neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Preprocedural Informative Animation Display About Echocardiography and Intraprocedural Kaleidoscope Display on Anxiety in Children
Objective: The study was conducted for the purpose of determining the effect of making children aged 5 to 12 years watch a cartoon about echocardiography (ECO) procedure before the procedure and kaleidoscope during the procedure on their anxiety.
Material and Method: It is a randomized controlled study. The study was completed with a total of 164 children who came to have an ECO and met the sample selection criteria. There were four groups in the study which were as follows; the group that was made watch a cartoon about the procedure before the procedure, the group that was made watch a kaleidoscope during the procedure, the group that was made watch a cartoon about the procedure before the procedure and a kaleidoscope during the procedure and the control group in which routine applications of clinic were carried out.
Results: At the end of the study, it was determined that anxiety scores of the cartoon group, cartoon+kaleidoscope group and the kaleidoscope group were lower during the procedure than before the procedure (p<0,001). In the control group, it was determined that there was no significant difference between the anxiety scores before and during the procedure (p>0,05).
Read the detailed description
The study was conducted for the purpose of determining the effect of making children aged 5 to 12 years watch a cartoon about echocardiography (ECO) procedure before the procedure and kaleidoscope during the procedure on their anxiety. It is a randomized controlled study. The study was conducted in the Pediatric Cardiology Polyclinic of Afyon Kocatepe University Ahmet Necdet Sezer Research and Application Hospital in the Province of Afyonkarahisar between 6 November 2018-1 February 2019. The study was completed with a total of 164 children who came to have an ECO and met the sample selection criteria. There were four groups in the study which were as follows; the group that was made watch a cartoon about the procedure before the procedure, the group that was made watch a kaleidoscope during the procedure, the group that was made watch a cartoon about the procedure before the procedure and a kaleidoscope during the procedure and the control group in which routine applications of clinic were carried out. Samples were assigned to the groups using permutation block randomization method. In order to collect data, an Introductory Information Form and the Child Fear Scale were used. The data acquired from the study were evaluated using the IBM SPSS Statistics 24 (Statistical Package for Social Sciences) package software. In our study, the experimental and control group children were found to be similar in terms of introductory characteristics (age, gender, educational level, family structure, number of children in family, illness and hospital experiences, information about ECO). At the end of the study, it was determined that anxiety scores of the cartoon group, cartoon+kaleidoscope group and the kaleidoscope group were lower during the procedure than before the procedure (p<0,001). In the control group, it was determined that there was no significant difference between the anxiety scores before and during the procedure (p>0,05).
- Conditions
- Anxiety, Child, Only, Echocardiography
- Being tested
- Cartoon group, Kaleidoscope group, Cartoon+Kaleidoscope group
- Keywords
- Child, Anxiety, Echocardiography, Cartoon, Kaleidoscope
- 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 5 minutes before echocardiography process.
Kaleidoscope groupOther
The children in the groups were distracted by kaleidoscope during echocardiography, until the process was over.
Cartoon+Kaleidoscope groupOther
The children in the groups were distracted by watching cartoon 5 minutes before echocardiography process and then the children in the groups were distracted by kaleidoscope during echocardiography, until the process was over.
| Study group | Role | What they receive |
|---|---|---|
| Cartoon group | Experimental | The children in the groups were distracted by watching cartoon 5 minutes before echocardiography. Receives: Other: Cartoon group |
| Kaleidoscope group | Experimental | The children in the groups were distracted by kaleidoscope during the echocardiography process, until the process was over. Receives: Other: Kaleidoscope group |
| Cartoon+Kaleidoscope group | Experimental | The children in the groups were distracted by watching cartoon 5 minutes before echocardiography and the children in the groups were distracted by kaleidoscope during the echocardiography process, until the process was over. Receives: Other: Cartoon+Kaleidoscope group |
| Control group | Experimental | No intervention was made to children in the control group Receives: Other: Cartoon group; Other: Kaleidoscope group; Other: Cartoon+Kaleidoscope group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children Fear Scale
The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural anxiety were evaluated
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 posted6 Apr 2020
- Study start6 Oct 2018
- Primary completion1 Feb 2019
- Study completion25 Dec 2019
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 Selcuk 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled experimental study was carried out with 164 children in the 5-12 age group in the pediatric echocardiography unit of a Training and Research Hospital between February 2019 and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Cartoon Group (n=41), Kaleidoscope Group (n=41), Cartoon+Kaleidoscope Group (n=41), Control group (Routine echocardiography) (41) . The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)".
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Responsible party
- Principal investigator, Birsel Molu, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334733
- Sponsor's protocol ID
- 2018/13 Osmangazi University
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 6 Apr 2020
- 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 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preprocedural Informative Animation Display About Echocardiography and Intraprocedural Kaleidoscope Display on Anxiety in Children
- ClinicalTrials.gov ID
- NCT04334733
- Acronym / sponsor ID
- 2018/13 Osmangazi University
- Conditions
- Anxiety, Child, Only, Echocardiography
- Keywords
- Child, Anxiety, Echocardiography, Cartoon, Kaleidoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Study start
- 6 Oct 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 6 Apr 2020 (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 conducted for the purpose of determining the effect of making children aged 5 to 12 years watch a cartoon about echocardiography (ECO) procedure before the procedure and kaleidoscope during the procedure on their anxiety.
Material and Method: It is a randomized controlled study. The study was completed with a total of 164 children who came to have an ECO and met the sample selection criteria. There were four groups in the study which were as follows; the group that was made watch a cartoon about the procedure before the procedure, the group that was made watch a kaleidoscope during the procedure, the group that was made watch a cartoon about the procedure before the procedure and a kaleidoscope during the procedure and the control group in which routine applications of clinic were carried out.
Results: At the end of the study, it was determined that anxiety scores of the cartoon group, cartoon+kaleidoscope group and the kaleidoscope group were lower during the procedure than before the procedure (p<0,001). In the control group, it was determined that there was no significant difference between the anxiety scores before and during the procedure (p>0,05).
Detailed description
The study was conducted for the purpose of determining the effect of making children aged 5 to 12 years watch a cartoon about echocardiography (ECO) procedure before the procedure and kaleidoscope during the procedure on their anxiety. It is a randomized controlled study. The study was conducted in the Pediatric Cardiology Polyclinic of Afyon Kocatepe University Ahmet Necdet Sezer Research and Application Hospital in the Province of Afyonkarahisar between 6 November 2018-1 February 2019. The study was completed with a total of 164 children who came to have an ECO and met the sample selection criteria. There were four groups in the study which were as follows; the group that was made watch a cartoon about the procedure before the procedure, the group that was made watch a kaleidoscope during the procedure, the group that was made watch a cartoon about the procedure before the procedure and a kaleidoscope during the procedure and the control group in which routine applications of clinic were carried out. Samples were assigned to the groups using permutation block randomization method. In order to collect data, an Introductory Information Form and the Child Fear Scale were used. The data acquired from the study were evaluated using the IBM SPSS Statistics 24 (Statistical Package for Social Sciences) package software. In our study, the experimental and control group children were found to be similar in terms of introductory characteristics (age, gender, educational level, family structure, number of children in family, illness and hospital experiences, information about ECO). At the end of the study, it was determined that anxiety scores of the cartoon group, cartoon+kaleidoscope group and the kaleidoscope group were lower during the procedure than before the procedure (p<0,001). In the control group, it was determined that there was no significant difference between the anxiety scores before and during the procedure (p>0,05).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This randomized controlled experimental study was carried out with 164 children in the 5-12 age group in the pediatric echocardiography unit of a Training and Research Hospital between February 2019 and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Cartoon Group (n=41), Kaleidoscope Group (n=41), Cartoon+Kaleidoscope Group (n=41), Control group (Routine echocardiography) (41) . The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)".
| Arm | Type | Receives |
|---|---|---|
| Cartoon group | Experimental | Other: Cartoon groupThe children in the groups were distracted by watching cartoon 5 minutes before echocardiography. |
| Kaleidoscope group | Experimental | Other: Kaleidoscope groupThe children in the groups were distracted by kaleidoscope during the echocardiography process, until the process was over. |
| Cartoon+Kaleidoscope group | Experimental | Other: Cartoon+Kaleidoscope groupThe children in the groups were distracted by watching cartoon 5 minutes before echocardiography and the children in the groups were distracted by kaleidoscope during the echocardiography process, until the process was over. |
| Control group | Experimental | Other: Cartoon group, Other: Kaleidoscope group, Other: Cartoon+Kaleidoscope groupNo intervention was made to children in the control group |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- being healthy
- ability to express himself/herself verbally
- no sedation taken in the last eight hours
- having no visual or auditory problems
- Ecocardiography process is to be held for the first time
Key exclusion criteria (3 listed)
- chronic disease
- 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 5 minutes before echocardiography process. | Other | Cartoon group, Control group |
| Kaleidoscope groupThe children in the groups were distracted by kaleidoscope during echocardiography, until the process was over. | Other | Control group, Kaleidoscope group |
| Cartoon+Kaleidoscope groupThe children in the groups were distracted by watching cartoon 5 minutes before echocardiography process and then the children in the groups were distracted by kaleidoscope during echocardiography, until the process was over. | Other | Cartoon+Kaleidoscope group, Control group |
Primary outcome
Children Fear Scale
Time frame: 1 minute
The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural anxiety were evaluated
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 6 Apr 2020.
- 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 Cartoon group, Kaleidoscope group and Cartoon+Kaleidoscope group in people with Anxiety and Child, Only, run by Selcuk 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 5 inclusion and 3 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 6 Apr 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). 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 6 Apr 2020.