Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.
Primary Purpose
Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cartoon
Sponsored by
About this trial
This is an interventional other trial for Anxiety focused on measuring preoperative anxiety, paediatric patients, Cartoon
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
Sites / Locations
- Balikesir University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
cartoon
routine
Arm Description
paediatric patients undergoing general anesthesia. This group will choose a cartoon movie to watch throughout the preparation until the induction of anesthesia
paediatric patients undergoing general anesthesia
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
family anxiety scores
the anxiety score of the parents is going to be evaluated before the operation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02185976
Brief Title
Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.
Official Title
Preoperative Anxiety in Paediatric Patients; do Cartoons Help?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balikesir University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
preoperative anxiety, paediatric patients, Cartoon
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cartoon
Arm Type
Active Comparator
Arm Description
paediatric patients undergoing general anesthesia. This group will choose a cartoon movie to watch throughout the preparation until the induction of anesthesia
Arm Title
routine
Arm Type
No Intervention
Arm Description
paediatric patients undergoing general anesthesia
Intervention Type
Other
Intervention Name(s)
cartoon
Intervention Description
5 different cartoons which will be recorded on a tablet PC.
Primary Outcome Measure Information:
Title
anxiety score
Description
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.
Time Frame
at the beginning and before induction of anesthesia
Secondary Outcome Measure Information:
Title
family anxiety scores
Description
the anxiety score of the parents is going to be evaluated before the operation.
Time Frame
Before operation during the first examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafize Fi Demir, Assist. Prof
Organizational Affiliation
Balikesir University School of Medicine Department of Anesthesia and Reanimation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balikesir University Faculty of Medicine
City
Balikesir
ZIP/Postal Code
10145
Country
Turkey
12. IPD Sharing Statement
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Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.
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