AnxietyNCT02185976
Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.
A study testing cartoon in people with Anxiety, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a special group who need special attention. Some studies have shown that cartoons are a very good tool for distraction in the preoperative period for children. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Anxiety
- What is being tested?
- cartoon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Dec 2020
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- family approval
- age between 3-9
- scheduled for surgery under general anesthesia
Who cannot join
- history of physiatric disease
- regular medication
- previous history of anesthesia/sedation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balikesir University Faculty of Medicine
Balıkesir, 10145
About this study
Official title: Preoperative Anxiety in Paediatric Patients; do Cartoons Help?
Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a special group who need special attention. Some studies have shown that cartoons are a very good tool for distraction in the preoperative period for children.
Our hypothesis is that children watching Cartoons in the preoperative period will have less anxiety and will be fit with preparation.
Read the detailed description
After local ethics committee approval 60 patients scheduled for various types of surgery will be included.
On the operation day patients are going to be evaluated in the preoperative preparation room. For anxiety evaluation the modified yale preoperative anxiety scale will be used. After this first evaluation patients are going to be separated randomly into two groups; group R (routine) and group C (cartoon). All patients are going to be premedicated with midazolam. The first group will receive their premedication straight after the first evaluation and their response will be recorded as easy, moderate, difficult, does not accept. Group C will choose a cartoon movie (5 different movies are recorded and will be shown through a tablet PC)) and will begin to watch it. After 5 minutes they will receive their premedication and their response will also be recorded. After 30 minutes a physician will try to insert an IV line and the response of the child will also be evaluated and recorded as easy, moderate, difficult and does not allow. Afterwards the patient will be transported into the operation room. In the operation room anesthesia will be induced via Sevoflurane and the response to mask anesthesia will be evaluated with the mask score as it is described before in previous studies. Patients in Group C will continue to watch the cartoon movie until the induction of anesthesia. And the modified yale score will also be reevaluated and recorded.
The family anxiety will be evaluated with the State Trait Anxiety Inventory Scale.
The family and the child will also be interviewed separately, 4 prepared standard questions will be asked in order to understand how the family described the operation.
- Conditions
- Anxiety
- Being tested
- cartoon
- Keywords
- preoperative anxiety, paediatric patients, Cartoon
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cartoonOther
5 different cartoons which will be recorded on a tablet PC.
| Study group | Role | What they receive |
|---|---|---|
| cartoon | Active comparator | paediatric patients undergoing general anesthesia. This group will choose a cartoon movie to watch throughout the preparation until the induction of anesthesia Receives: Other: cartoon |
| routine | No intervention | paediatric patients undergoing general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety score
the anxiety score of included patients is going to be evaluated at the beginning in the preparation room and once again in the operation room before induction.
Measured: at the beginning and before induction of anesthesia
Secondary outcomes (1)
family anxiety scores
the anxiety score of the parents is going to be evaluated before the operation.
Measured: Before operation during the first examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hafize fisun demir, Balikesir University
- Investigators
- Hafize Fi Demir, Assist. Prof, Principal investigator, Balikesir University School of Medicine Department of Anesthesia and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185976
- Sponsor's protocol ID
- 2013/051
- Status last verified
- Jan 2020
- First submitted
- 4 Jul 2014
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Anxiety in Paediatric Patients; do Cartoons Help?
- ClinicalTrials.gov ID
- NCT02185976
- Acronym / sponsor ID
- 2013/051
- Conditions
- Anxiety
- Keywords
- preoperative anxiety, paediatric patients, Cartoon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Jul 2014 (estimated)
- 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.
Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a special group who need special attention. Some studies have shown that cartoons are a very good tool for distraction in the preoperative period for children.
Our hypothesis is that children watching Cartoons in the preoperative period will have less anxiety and will be fit with preparation.
Detailed description
After local ethics committee approval 60 patients scheduled for various types of surgery will be included.
On the operation day patients are going to be evaluated in the preoperative preparation room. For anxiety evaluation the modified yale preoperative anxiety scale will be used. After this first evaluation patients are going to be separated randomly into two groups; group R (routine) and group C (cartoon). All patients are going to be premedicated with midazolam. The first group will receive their premedication straight after the first evaluation and their response will be recorded as easy, moderate, difficult, does not accept. Group C will choose a cartoon movie (5 different movies are recorded and will be shown through a tablet PC)) and will begin to watch it. After 5 minutes they will receive their premedication and their response will also be recorded. After 30 minutes a physician will try to insert an IV line and the response of the child will also be evaluated and recorded as easy, moderate, difficult and does not allow. Afterwards the patient will be transported into the operation room. In the operation room anesthesia will be induced via Sevoflurane and the response to mask anesthesia will be evaluated with the mask score as it is described before in previous studies. Patients in Group C will continue to watch the cartoon movie until the induction of anesthesia. And the modified yale score will also be reevaluated and recorded.
The family anxiety will be evaluated with the State Trait Anxiety Inventory Scale.
The family and the child will also be interviewed separately, 4 prepared standard questions will be asked in order to understand how the family described the operation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cartoon | Active comparator | Other: cartoonpaediatric patients undergoing general anesthesia. This group will choose a cartoon movie to watch throughout the preparation until the induction of anesthesia |
| routine | No intervention | –paediatric patients undergoing general anesthesia |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- family approval
- age between 3-9
- scheduled for surgery under general anesthesia
Key exclusion criteria (3 listed)
- history of physiatric disease
- regular medication
- previous history of anesthesia/sedation
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 |
|---|---|---|
| cartoon5 different cartoons which will be recorded on a tablet PC. | Other | cartoon |
Primary outcome
anxiety score
Time frame: at the beginning and before induction of anesthesia
the anxiety score of included patients is going to be evaluated at the beginning in the preparation room and once again in the operation room before induction.
1 secondary outcome
family anxiety scores
Time frame: Before operation during the first examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 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.
Hafize Fi Demir, Assist. Prof principal investigator
Balikesir University School of Medicine Department of Anesthesia and Reanimation
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 in people with Anxiety, run by Balikesir 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 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: status not confirmed, as of the sponsor's last update on 21 Jan 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?
Results are not available in the source record.
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?
anxiety score (time frame: at the beginning and before induction of anesthesia). 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 21 Jan 2020.