Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.

NCT ID: NCT02185976

Last Updated: 2020-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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cartoon

paediatric patients undergoing general anesthesia. This group will choose a cartoon movie to watch throughout the preparation until the induction of anesthesia

Group Type ACTIVE_COMPARATOR

cartoon

Intervention Type OTHER

5 different cartoons which will be recorded on a tablet PC.

routine

paediatric patients undergoing general anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cartoon

5 different cartoons which will be recorded on a tablet PC.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Balikesir University

OTHER

Sponsor Role lead

Responsible Party

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hafize fisun demir

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hafize Fi Demir, Assist. Prof

Role: PRINCIPAL_INVESTIGATOR

Balikesir University School of Medicine Department of Anesthesia and Reanimation

Locations

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Balikesir University Faculty of Medicine

Balıkesir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2013/051

Identifier Type: -

Identifier Source: org_study_id

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