Clinical trial NCT02185976: Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.
Official title: Preoperative Anxiety in Paediatric Patients; do Cartoons Help?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: preoperative anxiety
paediatric patients
Cartoon
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* family approval
* age between 3-9
* scheduled for surgery under general anesthesia

Exclusion Criteria:

* history of physiatric disease
* regular medication
* previous history of anesthesia/sedation

Primary outcomes:
measure: anxiety score
timeFrame: at the beginning and before induction of anesthesia
Secondary outcomes:
measure: family anxiety scores
timeFrame: Before operation during the first examination
Other outcomes:
Locations:
city: Balikesir
country: Turkey
facility: Balikesir University Faculty of Medicine
Study officials:
affiliation: Balikesir University School of Medicine Department of Anesthesia and Reanimation
name: Hafize Fi Demir, Assist. Prof
role: PRINCIPAL_INVESTIGATOR
References: