Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06027359 |
| Other study ID # |
AdnanMU-ÇSHH-FKD-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Aydin Adnan Menderes University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In processes such as illness, hospital, medical procedures, and nursing interventions, the
fears experienced by children should be reduced before the procedure. It may be more
effective to give interventions to reduce children's fears in a school setting rather than in
a complex environment such as a hospital. In this context, there is a need for experimental
studies that reveal the effect of therapeutic play on nursing interventions and fear of
medical materials in preschool children.
Description:
Entrance: In processes such as illness, hospital, medical procedures, and nursing
interventions, the fears experienced by children should be reduced before the procedure. It
may be more effective to give interventions to reduce children's fears in a school setting
rather than in a complex environment such as a hospital. In this context, there is a need for
experimental studies that reveal the effect of therapeutic play on nursing interventions and
fear of medical materials in preschool children.
Aim: This study was planned to determine the effect of therapeutic play on nursing
interventions and fear of medical materials in preschool children.
Method/ Data Collection Techniques:This research was planned as a quasi-experimental study
with pretest-posttest and control group. The universe of the research will consist of 170
children studying in pre-school classes at the Chamber of Commerce Primary School located in
the city center of Aydın. The sample size of the study was calculated using G*power analysis
and it was found that a total of 70 children (study: 35 children, control: 35 children).
However, considering the losses from the research and the possibility of children filling in
the questionnaires incomplete or incorrectly, the number of children was increased by 10% and
it was planned to complete the study with 80 (study: 40 children, control: 40 children)
children. It is planned to collect the data between March 1 and June 1, 2023. The child to be
included in the study and their parents will be informed about the study, verbal consent will
be obtained from the children and written consent will be obtained from the parents. After
obtaining parental consent about the study, the parents of the children in both the study and
control groups will have to fill in the "Introductory Information Form" and the children will
fill in the "Scale of Fear of Nursing Interventions and Used Materials in Children" before
the therapeutic play. The therapeutic game content to be applied to the study group consists
of four sessions organized by considering nursing interventions and materials used in the
hospital. In each session, various game activities will be held with different materials.
Therapeutic play activity will not be planned for the children in the control group. One week
after the therapeutic play activities are completed, the children will have to fill out the
"Scale of Fear Against Nursing Interventions and Used Materials in Children".
The data obtained in the research will be analyzed using the SPSS (Statistical Package for
Social Sciences) for Windows 22.0 program. Homogeneity of descriptive features between groups
will be tested by chi-square analysis. The Kolmogorov Smirnov Test will be used to determine
whether the research data are normally distributed. In the analysis of study data,
descriptive statistics, if the data show normal distribution, independent group-t-test and
changes within the group repeated measurements Anova test; If it does not have a normal
distribution, Mann Whitney-U test and Wilcoxon signed-rank test will be used.
Expected Results: Thanks to the results obtained from this study, it is expected that the
familiarity of children with nursing interventions and materials with the therapeutic play
method in their own environment such as school will help them experience less fear and adapt
easily during a possible hospital experience in the future.
