Effect of Cartoons on Preoperative Anxiety in Paediatric... | NCT02185976

Studies
Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.

NCT02185976

Sponsor

Balikesir University

Status

Unknown status

Last Update Posted

Jan 21, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Anxiety

Interventions

cartoon

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Aug 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jul 4, 2014

First Submission Date that Met QC Criteria

Jul 9, 2014

First Posted Date

Jul 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2020

Last Update Posted Date

Jan 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

hafize fisun demir, Assistant Professor, Balikesir UniversityPrincipal Investigator

Lead Sponsor

Balikesir UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Other: cartoon
routine	No Intervention	paediatric patients undergoing general anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cartoon	Other	5 different cartoons which will be recorded on a tablet PC.	cartoon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
family anxiety scores	the anxiety score of the parents is going to be evaluated before the operation.	Before operation during the first examination

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hafize Fi Demir, Assist. Prof	Balikesir University School of Medicine Department of Anesthesia and Reanimation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Balikesir University Faculty of Medicine		Balıkesir		10145	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided