The Effect of Projector Kaleidoscope and Cartoons on Anxiety, Fear, and Pain in Children

November 19, 2024 updated by: Atiye Karakul, Tarsus University

The Effect of Projector Kaleidoscope and Cartoons in the Operating Room on Anxiety, Fear and Pain in Children Aged 4-10 Who Will Undergo Outpatient Surgery

The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria.

The population of the study, which is planned as a randomized controlled experimental study, will consist of children aged 4-10 years old who are admitted to the pediatric surgery service of Tarsus State Hospital and will undergo outpatient surgical intervention.

In collecting research data; the Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Wong-Baker Pain Scale and Vital Signs Follow-up Form will be used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria.

The population of the study, which is planned as a randomized controlled experimental study, will consist of children aged 4-10 years old who are admitted to the pediatric surgery service of Tarsus State Hospital and will undergo outpatient surgical intervention.

In collecting research data; the Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Wong-Baker Pain Scale, and Vital Signs Follow-up Form will be used.

Collection of Data The research will be implemented after ethics committee approval and written institutional permission are obtained.

Stage 1: By consulting experts on the subject, the researchers will create a pool of cartoons suitable for the level of children in the 4-10 age group that they can watch. The created children's cartoon pool will be sent to people who are experts in the field (child development specialists, child psychiatrists, and pediatric nurses).

Stage 2: Data collection forms to be used before the research. A pilot study will be conducted with 10 children to evaluate the suitability of the cartoon for children.

Stage 3: The children and their parents in the sample group will be informed about the method followed in the application and the research, and their verbal and written permissions will be obtained.

Stage 4: The introductory information form in the research will be applied to the children in the sample group.

Stage 5: Randomization will be achieved by randomly and equally distributing patients who meet the sample selection criteria to 3 groups (1st experimental group, 2nd experimental control group and 3rd group control group) through a computer program.

(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html). Stage 6: Children in the projector kaleidoscope group will be watched for approximately 5 minutes before induction in the operating room. Children in the cartoon group will be asked which cartoon they want to watch from the cartoon pool and will be shown the cartoon they want. The cartoon duration is approximately 5 minutes.

Stage 7: Before the surgery, the anxiety, fear and vital signs of the children in the sample will be evaluated. Children's fear assessment will be done by both the child and the nurse. Since parents are not allowed into the operating room, the evaluation will be made only by the child and the nurse.

Stage 8: In the postoperative period, the anxiety, fear, vital signs and pain of the children in the experimental and control groups will be recorded. Children's fear and pain assessment will be done by the child, nurse and parent.

Analysis of Research Data:

The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods (number, percentage, min-max values, mean, and standard deviation) will be used when evaluating the data. The suitability of the data used for normal distribution will be checked with kurtosis and skewness values. In comparing quantitative data with normally distributed data, an independent t-test will be used for the difference between two independent groups. In comparing more than two dependent groups, analysis of variance will be applied in repeated measurements and in case of a difference, Bonferroni will be used to find the group that makes the difference. In comparing quantitative data in non-normally distributed data, the Mann-Whitney U test will be applied for the difference between two independent groups, and in comparing more than two dependent groups, the Friedman test will be applied, and in case of a difference, the corrected Bonferroni will be used to find the group that makes the difference. Chi-square analysis will be applied to test the relationship between categorical variables. Cohen's Kappa Test will be applied in interobserver agreement analysis.

Study Type

Interventional

Enrollment (Actual)

90

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
      • Mersin, Turkey
        • Tarsus State Hospital

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

No

Description

Inclusion Criteria:

  • Being between the ages of 4-10
  • Having outpatient surgery
  • Volunteering to participate in the study

Exclusion Criteria:

  • Having had a previous surgical intervention
  • Having a chronic disease
  • The child has visual, hearing, and mental disabilities

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Projector Kaleidoscope
Children in the projector kaleidoscope group will be watched for approximately 5 minutes before induction into the operating room.
Other: Projector Kaleidoscope
Children in the projector kaleidoscope group will be watched for approximately 5 minutes before induction in the operating room.
Experimental: Cartoon
Children in the cartoon group will be asked which cartoon they want to watch from the cartoon pool and will be shown the cartoon they want. The cartoon duration is approximately 5 minutes.
Other: Cartoon
Children in the cartoon group will be asked which cartoon they want to watch from the cartoon pool and will be shown the cartoon they want. The cartoon duration is approximately 5 minutes.
No Intervention: Control
Routine care will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 1 day
Child Anxiety Scale-State scale will be used. The scale is shaped like a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. This scale, for children ages 4 to 10, asks children, "Imagine that all your anxious or nervous emotions are in the bulb or bottom part of the thermometer" or "If you're a little anxious or nervous, the emotions might move up a little bit on the thermometer." If you're very, very anxious or nervous, emotions can run rampant. "Put a line on the thermometer that shows how anxious or angry you are." To measure state anxiety, the child is asked to indicate what he or she is feeling "right now." The score can vary between 0 and 10
1 day
Fear
Time Frame: 1 day
"Children's Fear Scale" will be used. This Scale includes 5 different facial expressions. This scale is scored between 0-4 and is stated to be a reliable and valid measurement tool in the assessment of fear.
1 day
Pain after surgery
Time Frame: 1 day
The Wong-Baker scale will be used. There are six facial expressions scored from zero to five. The Wong-Baker Scale has faces that indicate increasing pain intensity from zero to five from left to right.
1 day

Collaborators and Investigators

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

Sponsor

Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2024

Primary Completion (Actual)

November 19, 2024

Study Completion (Actual)

November 19, 2024

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/09

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

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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