Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05185830 |
Other study ID # |
2020.17 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 29, 2021 |
Est. completion date |
June 1, 2022 |
Study information
Verified date |
October 2022 |
Source |
Trakya University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This project will be conducted with 5-10-year-old children who will undergo an outpatient
surgery in Trakya University Health Research and Application Center at Pediatric Surgery
Clinic and their parents. It is reported in the literature that technology-based applications
and robot use are promising innovations in reducing pain, anxiety, and fear in children. This
was the main starting point in the planning of the study. In this study, by using interactive
robot, it was aimed to reduce postoperative mobilization anxiety, to increase frequency /
duration of the mobilization and to increase parental satisfaction of the children undergoing
outpatient surgery.
Description:
The use of interactive robots is expected to reduce the child's anxiety by ensuring that the
child is physically, psychologically, and socially optimal. It is foreseen that the child
with reduced anxiety will be willing to mobilize with the interactive robot and it will
increase the mobilization time and the frequency of the mobilization during the day.
Decreasing the anxiety of children and increasing the desire for mobilization will increase
the satisfaction of the families.
The study will be conducted with 84 children (42 Experiment + 42 Control) aged 5-10 years.
The study was planned as a randomized controlled study. Data will be collected by
"Questionnaire Form" and "Child Anxiety Scale-State Anxiety" and Parental Satisfaction
Scoring-Visual Analog Scale" and "Mobilization Chart". Families will be informed about the
research and before the surgery, families, and children in both groups will be informed about
the benefits of mobilization. Two hours after the operation, just before the mobilization,
the children in the experimental group will be introduced to the robot, and the children in
the control group will be asked to mobilize with their parents.
When the child is first mobilized at the time recommended by the physician for all groups
after the surgery, the child's anxiety for mobilization will be assessed using the Child
Anxiety Scale (State Anxiety). The mobilization time of the children will be measured by
stopwatch and recorded in the Mobilization Schedule together with the frequency of
mobilization. Parental Satisfaction Scale- Visual Analogue Scale will be applied to evaluate
the satisfaction of the parents towards the application.