Effect of Animated Cartoon for Prevention of Emergence Agitation in Children Aged 1.5 - 5 yr After General Anesthesia

June 13, 2013 updated by: Yonsei University
Emergence agitation (EA) in children early after sevoflurane anaesthesia is a common postoperative problem, with incidence ranging up to 80%. Younger patients, particularly in the age range from 1.5 to 5 yr of age, are at increased risk of EA. Preoperative anxiety, as measured by the modified Yale Preoperative Anxiety Scale, has been shown to increase the risk of EA for each increment of 10 points in the child's state anxiety score. So, Alleviates preoperative anxiety in Children maybe decrease the incidence and severity of EA. Preschool children enjoy watching animated cartoons, and they can be immersed to animated cartoon so they become oblivious of their surroundings. Therefore, viewing an animated cartoon maybe reduce preoperative anxiety in children. This study was performed to determine effect of animated cartoon for prevention of emergence agitation in children aged 1.5 - 5 yr after general anesthesia

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
        • Contact:
          • Jeong-Rim LEE, MD, PhD
          • Phone Number: 02-2227-3840
          • Email: MANYA@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. pediatric patient (1.5-5yrs) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia

Exclusion Criteria:

1. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: watching animated cartoon
Other: watching animated cartoon before general anesthesia
Placebo Comparator: not watching animated cartoon
Other: not watching animated cartoon beofre general anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Anesthesia Emergence Delirium (PAED) Scale
Time Frame: (PAED) Scale changes from the moment subjects open their eyes, and every 5 minute for 24hours
Subjects' behavior was rated in the post-anesthesia care unit (PACU) from the moment subjects opened their eyes, and every 5 minutes until discharge from the PACU. The Pediatric Anesthesia Emergence Delirium (PAED) Scale (Sikich & Lerman, 2004) was used. The scale assesses 5 behaviors (making eye contact, purposefulness of actions, awareness of surroundings, restlessness, and consolability) on a 5-point scale that ranges from 'not at all' to 'extremely'.
(PAED) Scale changes from the moment subjects open their eyes, and every 5 minute for 24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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