Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT05790005
Brief Summary:
The goal of this experimental study is to determine the effect of therapeutic play method applied to hospitalized children aged 7-12 before the first surgical dressing attempt, on anxiety and fear. Researcher will compare the study and control groups to see if therapeutic play has an effect on anxiety and fear.
Detailed Description:
G-Power 3.1.9.4 package program was used for sample size calculation in the study. Children will be assigned to the study and control groups using the www.randomizer.org program with a simple randomization method to ensure homogeneity between the study and control groups. Before dressing, a warm-up play will be played for 10 minutes with the study group, followed by a 20-minute therapeutic game in which the dramatization method will be used. The children in the control group will be subjected to the routine dressing procedure. The data of the research will be collected using the Child and Parent Information Form, Child Anxiety Scale-State Scale and Child Fear Scale.
During the evaluation of the data, the sociodemographic characteristics of the groups participating in the study will be stated as numbers and percentages, and the normal distribution of the anxiety scale and fear scale scores before the play, after the play and after the dressing process in the Intervention and control groups will be determined by looking at the skewness coefficients. The Factorial Anova Test will be used for mixed measurements in order to examine the anxiety and fear changes of the children in the Intervention and control groups before the play, after the play and after the dressing process. In addition, since this test does not measure the different changes between the groups, the Anova Test in Repeated Measurements will be used to compare the anxiety and fear scores of only the Intervention group and only the control group before the play, after the play and after the dressing process. If the data do not have a normal distribution, the Friedman Test, which is a nonparametric test, will be used.
Study:
NCT05790005
Study Brief:
Protocol Section:
NCT05790005