NCT02185976

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

6.6 years

First QC Date

July 4, 2014

Last Update Submit

January 17, 2020

Conditions

Anxiety

Keywords

preoperative anxietypaediatric patientsCartoon

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • family anxiety scores

    Before operation during the first examination

Study Arms (2)

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

cartoonOTHER

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

cartoon

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University Faculty of Medicine

Balıkesir, 10145, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Hafize Fi Demir, Assist. Prof

    Balikesir University School of Medicine Department of Anesthesia and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 10, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2020

Study Completion

December 1, 2020

Last Updated

January 21, 2020

Record last verified: 2020-01

Locations

TU(1)