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Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06339047
Study type Interventional
Source Tarsus University
Contact Atiye Karakul, Assoc. Prof.
Phone +9003246000033
Email atiyekarakul@gmail.com
Status Not yet recruiting
Phase N/A
Start date June 1, 2024
Completion date December 1, 2024

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