Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05478369 |
| Other study ID # |
B.30.2.ATA.0.01.00/554 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 19, 2022 |
| Est. completion date |
August 19, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this project is to determine the effect of reading the story book, which is
considered within the scope of the pedagogically approved research that introduces the
surgical environment before the surgical intervention in children, on the pain and anxiety of
the child. The project is a randomized controlled trial. The population of the research will
be children between the ages of 4 and 6 who come to Atatürk University Health Research and
Application Center Pediatric Surgery Clinic between March and September 2022 for treatment.
The research sample; children and parents who are hospitalized in the clinic on the dates
specified by the probabilistic sampling method and meet the research criteria, willing to
participate in the research. "Survey Form", "Modified Yale Preoperative Anxiety Scale
(mYPAS)" and "Child Fear Scale" will be used in data collection.
Description:
Type of Study: The study is of the randomized controlled experimental type. Place and Time of
the Research: The research will be carried out between March-September 2022 at Atatürk
University Health Research and Application Center Pediatric Surgery Clinic. Surgical
procedures performed in the clinic are frequently prepuce, hernias, undescended testis, acute
abdominal traumas and dilatation.
Population and Sample of the Study: The population of the research will be children aged 4-6
years who come to Atatürk University Health Research and Application Hospital Pediatric
Surgery Clinic between March-September 2022 for treatment.
The research sample; hernia and undescended testis will be operated on the dates specified by
the probabilistic sampling method and children who meet the research criteria and volunteer
to participate in the research will be formed.
In order to prevent interaction between the groups of children in the clinic, data collection
will not be carried out simultaneously in the story group and control groups. In order to
ensure randomization, children who met the criteria will be included in the control group in
the first week, and children who come in the second week will be included in the story group,
and this cycle will be continued until the end of the study and randomization will be
ensured.
Data Collection Tools: Questionnaire Form, Modified Yale Preoperative Anxiety Scale and Child
Fear Scale will be used to collect research data. The book titled "Elif Is Surgery", which is
licensed by Çamlıca Children's Publishing, which owns the copyrights, will be used as an
intervention tool in the research.
Questionnaire Form: In this form, which was prepared by the researcher by examining the
literature; There will be questions about the introductory features of the child and the
parent.
Modified Yale Preoperative Anxiety Scale (mYPAS): The Yale Preoperative Anxiety Scale (YPAS),
which was developed in 1995 to measure the preoperative anxiety of children, was modified in
1997 (mYPAS) and used in many studies covering various health fields such as dentistry,
anesthesia, surgery, and pediatrics. The scale evaluates five basic parameters. These;
Activity includes speech, emotional state, marked arousal, and relationship with family. In
the scale, the parameters of activity, emotional state, marked arousal state and relationship
with family are evaluated between (1-4) and speech (1-6).
Child Fear Scale (CFS): Child Fear Scale was developed in 2011 to measure fear in children
undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five
faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious
anxiety).
Intervention Tool to be Used in Research Storybook: As an intervention tool in the research,
the book titled "Elif Is Surgery" will be read by her parents.
In the selection of the story book, attention was paid to the fact that it was pedagogically
appropriate and at the same time the author of the book was a child developmentalist and
pedagogue. In this storybook, the operating environment is introduced in a way that children
can understand and is suitable for the age group of the study. Words such as cut and blood,
which are specific to this age, are not used in the storybook. While the story book will be
read, the child's opinion will be taken and the book will be read with a character name that
he wants. For example, ask the children, "What name would you like to give your character
before the book is read?" Asking the child's opinion will increase his self-confidence, and
at the same time, it will be ensured that he listens carefully to the story with the
curiosity of "What will happen to my character?" Data Collection The researcher will be in
the pediatric surgery service for 2 days to examine the pediatric surgery service and will
make a preliminary application before collecting the data of the children in the storybook
group and the control group children. The children and their parents were given preliminary
information about the research (the purpose of the research, why the research was conducted,
the story book would be used to relieve the child's fear and anxiety, it was thought that it
would be effective in preventing fear, etc.) will be obtained through face-to-face
interviews.
Control Group: Questionnaires and scales will be filled by the researcher 30 minutes before
the surgery. Only routine applications will be done within 5 minutes. The scales will be
refilled 10 minutes before the surgery and when the child moves to the premedication room.
The families of the children will be with the children until the premedication room. Filling
out the forms will take 5-10 minutes on average.
Story Group: Questionnaires and scales will be filled in 30 minutes before the surgery by the
researcher. The child's parent will read the storybook. In reading the story book; It will
reduce fear and anxiety by attracting the patient's attention (sound, image…) and enabling
him to get away from the negative emotions he is in. Routine applications will be done within
5 minutes. The scales will be refilled 10 minutes before the surgery and when the child moves
to the premedication room. The families of the children will be with the children until the
premedication room. Filling out the forms will take 5-10 minutes on average.
Evaluation of Data The processing and statistical analysis of the collected data will be done
with the analysis software called SPSS (Statistical Package for the Social Sciences) for
Windows 20.0.
Ethical Principles of Research In order to carry out the research, official permission from
the relevant institution will be obtained from the Ethics Committee with ethical approval.
Children who meet the criteria of the research group will be informed about the purpose of
the study, their questions will be answered, and their verbal and written consent will be
obtained. Parents and children will be informed that the data collected during the research
will be processed anonymously, confidentially, and will not be used outside of the study in
question, and that they can leave the study whenever they wish. Since the research is based
on the use of data obtained from humans, and therefore, due to the necessity of observing
personal rights, the relevant ethical principles "Informed Consent", "Volunteerism" and
"Protection of Confidentiality" will be followed.
