Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05099302 |
| Other study ID # |
CARTOONS1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 14, 2021 |
| Est. completion date |
August 27, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Karamanoglu Mehmetbey University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study was conducted as a randomized controlled experimental study to determine the
effect of cartoon in reducing pre-operative fear in children aged 4-10 years who came to the
operating room. The data of the study were obtained from children between 4-10 years old who
came to Mersin University Hospital Operating Room Unit between 1 July and 30 August 2020. The
sample size was determined as a total of 116 children, including 58 children for each group.
"Observation Form, Children's Fear Scale (CFS), Tablet Computer, Stopwatch" was used for data
collection. The data were evaluated using percentage, mean, standard deviation, chi-square, t
test, Anova and Tukey advanced analysis test.
Cartoons group; When the children came to the operating room waiting room, the first
stopwatch was started as soon as they entered the room to determine the length of stay in the
waiting room, and it was turned off while they were entering the operating room with the
anesthesiologist. Thus, the total length of stay in the room was determined and recorded. The
second stopwatch was started as soon as the child began to cry, and was turned off when the
crying stopped. Thus, the crying time of each child was also evaluated. After each parent
signed the Informed Consent Form, the Interview and Observation Form was filled. Then the
child's heart rate was measured and recorded. The child's fear level was evaluated separately
by the child, parent and observer via CFS and recorded in the data collection form. After the
initial assessment was completed, the child was asked if he wanted to watch cartoons. "Snow
Queen" for girls who want to watch cartoons and "Spider-Man" cartoons for boys started to be
watched by tablet. The period of watching cartoons lasted until the child left the waiting
room. The heart rate was measured just before the child left the waiting room at the time of
surgery. The level of fear was evaluated separately by the child, parent and observer via CFS
and recorded in the form. Then, the child was taken to the operating room with the
anesthesiologist and observer. Parents are separated from their children in the waiting room.
After the child who came to the operating room was taken to the operating table, the pulse
rate and the level of fear were evaluated and recorded by the observer via CFS.
Control group: All processing steps were carried out similarly to the cartoon group. In this
group, the option of playing toys was offered instead of cartoons.
Description:
The research will be carried out in the Operating Room Unit of X University Hospital. There
are 20 surgical specialists, eight anesthesiologists, 35 nurses, 25 anesthesia technicians,
30 support personnel, and personnel working in 13 different areas (such as secretary,
consumables warehouse manager) in the operating room unit. The personnel working in the unit
working in shifts work in shifts between 08.00-16.00, 16.00-08.00 and 16.00-24.00. There are
16 operating rooms in total in the operating room unit. Apart from these rooms, there are
pre-operative patient waiting room, pre-operative pediatric waiting room and postoperative
patient/children's rooms. There are also rest rooms for the personnel working in the
operating room and a 10-bed reanimation unit. The pre-operative pediatric waiting room is
located at the patient admission entrance of the operating room and is not a sterile area. It
has an average size of 40 m2 and includes a television, two beds, two armchairs and toys.
There are cartoon characters and pictures on the walls of the waiting room. Before the
operation, children spend an average of 5-20 minutes in the children's waiting room after the
operation. is brought first. After the necessary procedures are performed by the preop nurse,
the child is taken to the operating room in the presence of an anesthesiologist and
anesthesiologist.
The sample size was calculated with 95% power, with 10% difference at 0.05 significance
level, taking into account the known score (4.53 ± 3.23) with the G*Power 3.1.5 program. The
sample size was determined as 58 children for each group. A total of 116 children were not
reached. At the end of the study, Post Hoc power analysis will also be carried out in order
to determine the adequacy of the number of children included in the study, and if 95% power
is reached, the data collection process will be terminated.
Randomization of control and study groups; The status of the children to be included in the
study in the control or study group will be determined by using "stratification and
randomization methods with blocks". In the literature, it has been reported that among the
factors affecting the fear and anxiety experienced by children in interventional procedures,
variables such as age, gender and fear of interventional procedure are included. Accordingly,
block randomization will be applied by stratifying the children as "girl and boy" for the
gender variable and "4 years, 5 years and 6 years and over" for the age variable. 58 children
will be included in each of the research groups. During the data collection process, each
child and his/her family will be taken to the operating room waiting room one by one. This
will prevent children from meeting each other.
