Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.

Anxiety Clinical Trial

Official title:

Preoperative Anxiety in Paediatric Patients; do Cartoons Help?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02185976
• Other study ID #: 2013/051
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Our hypothesis is that children watching Cartoons in the preoperative period will have less anxiety and will be fit with preparation.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• cartoon
5 different cartoons which will be recorded on a tablet PC.

Locations

Country	Name	City	State
Turkey	Balikesir University Faculty of Medicine	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Balikesir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at the beginning and before induction of anesthesia
Secondary	family anxiety scores	the anxiety score of the parents is going to be evaluated before the operation.	Before operation during the first examination