The Effect of Cartoons Watched Before Surgery on Children's Fear Level

January 9, 2025 updated by: Ayse Sonay Turkmen, Prof.Dr

This study was conducted as a randomized controlled experimental study to determine the effect of cartoon in reducing pre-operative fear in children aged 4-10 years who came to the operating room. The data of the study were obtained from children between 4-10 years old who came to Mersin University Hospital Operating Room Unit between 1 July and 30 August 2020. The sample size was determined as a total of 116 children, including 58 children for each group. "Observation Form, Children's Fear Scale (CFS), Tablet Computer, Stopwatch" was used for data collection. The data were evaluated using percentage, mean, standard deviation, chi-square, t test, Anova and Tukey advanced analysis test.

Cartoons group; When the children came to the operating room waiting room, the first stopwatch was started as soon as they entered the room to determine the length of stay in the waiting room, and it was turned off while they were entering the operating room with the anesthesiologist. Thus, the total length of stay in the room was determined and recorded. The second stopwatch was started as soon as the child began to cry, and was turned off when the crying stopped. Thus, the crying time of each child was also evaluated. After each parent signed the Informed Consent Form, the Interview and Observation Form was filled. Then the child's heart rate was measured and recorded. The child's fear level was evaluated separately by the child, parent and observer via CFS and recorded in the data collection form. After the initial assessment was completed, the child was asked if he wanted to watch cartoons. "Snow Queen" for girls who want to watch cartoons and "Spider-Man" cartoons for boys started to be watched by tablet. The period of watching cartoons lasted until the child left the waiting room. The heart rate was measured just before the child left the waiting room at the time of surgery. The level of fear was evaluated separately by the child, parent and observer via CFS and recorded in the form. Then, the child was taken to the operating room with the anesthesiologist and observer. Parents are separated from their children in the waiting room. After the child who came to the operating room was taken to the operating table, the pulse rate and the level of fear were evaluated and recorded by the observer via CFS.

Control group: All processing steps were carried out similarly to the cartoon group. In this group, the option of playing toys was offered instead of cartoons.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The research will be carried out in the Operating Room Unit of X University Hospital. There are 20 surgical specialists, eight anesthesiologists, 35 nurses, 25 anesthesia technicians, 30 support personnel, and personnel working in 13 different areas (such as secretary, consumables warehouse manager) in the operating room unit. The personnel working in the unit working in shifts work in shifts between 08.00-16.00, 16.00-08.00 and 16.00-24.00. There are 16 operating rooms in total in the operating room unit. Apart from these rooms, there are pre-operative patient waiting room, pre-operative pediatric waiting room and postoperative patient/children's rooms. There are also rest rooms for the personnel working in the operating room and a 10-bed reanimation unit. The pre-operative pediatric waiting room is located at the patient admission entrance of the operating room and is not a sterile area. It has an average size of 40 m2 and includes a television, two beds, two armchairs and toys. There are cartoon characters and pictures on the walls of the waiting room. Before the operation, children spend an average of 5-20 minutes in the children's waiting room after the operation. is brought first. After the necessary procedures are performed by the preop nurse, the child is taken to the operating room in the presence of an anesthesiologist and anesthesiologist.

The sample size was calculated with 95% power, with 10% difference at 0.05 significance level, taking into account the known score (4.53 ± 3.23) with the G*Power 3.1.5 program. The sample size was determined as 58 children for each group. A total of 116 children were not reached. At the end of the study, Post Hoc power analysis will also be carried out in order to determine the adequacy of the number of children included in the study, and if 95% power is reached, the data collection process will be terminated.

Randomization of control and study groups; The status of the children to be included in the study in the control or study group will be determined by using "stratification and randomization methods with blocks". In the literature, it has been reported that among the factors affecting the fear and anxiety experienced by children in interventional procedures, variables such as age, gender and fear of interventional procedure are included. Accordingly, block randomization will be applied by stratifying the children as "girl and boy" for the gender variable and "4 years, 5 years and 6 years and over" for the age variable. 58 children will be included in each of the research groups. During the data collection process, each child and his/her family will be taken to the operating room waiting room one by one. This will prevent children from meeting each other.

Study Type

Interventional

Enrollment (Actual)

116

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

      • Karaman, Turkey
        • Karamanoğlu Mehmetbey University
      • Karaman, Turkey, 70100
        • KaramanogluMehmetbeyU

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

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

the child;

  • Age between 4-10 years
  • Children's perception level to evaluate the scale of fear
  • The child does not have any physical or mental illness
  • The child's ability to communicate and be open to communication
  • The child does not have a hearing, speech or vision problem
  • The child does not have a long-term illness
  • The child and his parents agree to participate in the study.

Exclusion Criteria:

  • The child is less than 4 years old or over 10 years old,
  • The presence of any chronic disease, physical or mental illness that may affect the child's fear state
  • Child or family refusal to participate in the study

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cartoon group
In the research, the group whose fear was tried to be reduced by watching cartoons
In order to reduce the fears of the children who came to the waiting room before the operation, they watched cartoons and their attention was diverted to another point.
No Intervention: control group
The group whose change in the process was monitored without any intervention in the research

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear Scores
Time Frame: 15 minutes
Changes from Baseline in Visual Analogue Scale Fear Scores in Children with Operation-Related Fear Evaluated by CFS at Entrance to the Operating Room, Leaving the Waiting Room, and at the Operating Table.
15 minutes
Heart Rate
Time Frame: 15 minutes
Changes from Baseline in heart rate in Children with Operation-Related at Entrance to the Operating Room, Leaving the Waiting Room, and at the Operating Table.
15 minutes

Collaborators and Investigators

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

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)

January 14, 2021

Primary Completion (Actual)

August 27, 2021

Study Completion (Actual)

August 27, 2021

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CARTOONS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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