Preoperative Information With Storybook for Pediatric Anesthesia

April 23, 2024 updated by: Alkin Colak, Trakya University

The Effect of Storybook vs Standart Information on Anesthesia Anxiety in Preoperative Period in Pediatric Patients

Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. In this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

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

  • Turkey
    • Edi̇rne
      • Edirne, Edi̇rne, Turkey, 22030
        • Trakya University

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pediatric surgery patient including inguinal hernia repair, circumcision and tonsillectomy.
  • without having previous emergency surgery and anesthetic experience,

Exclusion Criteria:

  • Their parents reported developmental delays, mental retardation, or chronic illnesses of the children
  • Emergency surgery

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: storybook
Other: showing cartoons -storybook
A goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period
Placebo Comparator: standart
Other: showing cartoons - standard
standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
preoperative anxiety scale
Time Frame: baseline ( before induction of anesthesia)
baseline ( before induction of anesthesia)
State-trait anxiety inventory (STAI FORM TX-1, TX-2) for parents
Time Frame: baseline ( before induction of anesthesia)
baseline ( before induction of anesthesia)
Children's Hospital of Eastern Ontario Pain (CHEOP) Scale
Time Frame: Postoperative 0-24 hours
Postoperative 0-24 hours
Pediatric Anesthesia Emergence Delirium (PAED) scale
Time Frame: Postoperative 1 hour
Postoperative 1 hour

Collaborators and Investigators

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

Sponsor

Trakya 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 (Actual)

March 9, 2018

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

May 29, 2020

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Alkinstorybook

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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