Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06368947 |
| Other study ID # |
B.30.2.ATA.0.01.00/172 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 29, 2024 |
| Est. completion date |
December 29, 2026 |
Study information
| Verified date |
April 2024 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The research is a randomized controlled experimental study. The population of the research
will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia
and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana
City Training and Research Hospital between 19.05.2024 and 19.05.2025. Therapeutic play
sessions will occur over a 4-week period during chemotherapy treatment.
Description:
Type of Research: The research is a randomized controlled experimental study. Place and Time
of the Research: The research will be carried out at the Pediatric Hematology Clinic of Adana
City Training and Research Hospital between April 2024 and June 2026.
Population and Sample of the Research: The population of the research will consist of 10-18
year old children who were diagnosed with acute lymphoblastic leukemia and received
chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training
and Research Hospital between 19.05.2024 and 19.05.2025. In this study, G-power prior power
analysis was performed to determine the sample size. In the power analysis, it was determined
that if the study was conducted with a total of 60 participants in two groups with 30
participants in each group for the t test in independent groups, 80% power could be achieved
with a 95% confidence interval at a significance level of 0.05. It was decided to collect
data from a total of 66 children by including a 10% backup sample in this number in case of
data loss.
Therapeutic game: In the research, a preliminary application will be made first. A special
play bag will be created for each child patient, which will not threaten his health and can
be disinfected. Therapeutic play sessions will occur over a 4-week period during chemotherapy
treatment. Therapeutic game 2 days a week for a maximum of 60 minutes. It will be carried out
for 4 weeks.
Week 1: It will consist of meeting, building trust, giving information about the sessions,
and planning the therapeutic game. After the initial meeting and trust building stages,
activities will be held with emotion cards. Week 2: The researcher will carry out activities
that will enable the child to express his emotions through puppet making. A puppet with the
characteristics desired by the child will be made by the child and the researcher. The shape
and appearance of the puppet will be determined by the child.
Week 3: At this stage, after the puppet is completed, the drama will be created and realized
through the meaning given to the puppet and the emotions reflected. Emotions will be
discussed on the puppet, and the child will be helped to understand, express and analyze his
feelings.
Week 4: The child and the researcher will produce creative stories and the child's emotions
will be discussed. In the last sessions of this stage, the child will be comforted by using
the "healing stories for children" book.
Evaluation of Data The data will be analyzed with the SPSS for Windows 22 package program.
The normality distribution of the data will be determined by Kurtosis and Skewness
coefficients. In the analysis of the data, in addition to numbers, percentages, averages and
standard deviations, t-test will be used in independent groups for normally distributed
measurements and Mann Whitney U analysis will be used for non-normally distributed
measurements in comparing paired groups. Statistical significance will be accepted as p<0.05.
Ethical Principles of Research In order to conduct the research, official permission was
obtained from the relevant institution with ethical approval from the Ataturk University
Non-Interventional Clinical Research Ethics Committee. Clinical trials will be registered for
randomized controlled studies. The purpose of the study will be explained to children and
parents who meet the research group criteria, their questions will be answered, and their
verbal and written consent will be obtained. Children and parents will be informed that the
data collected during the research will be processed confidentially and anonymously, will not
be used outside of the study in question, and that they can leave the study at any time.
Since the research is based on the use of data obtained from humans, and therefore the need
to respect personal rights, the relevant ethical principles of "Informed Consent",
"Volunteering" and "Protection of Confidentiality" will be followed. The "Principle of
Equality" will be tried to be fulfilled by giving the children in the control group the same
game bags given to the children in the intervention group.
