Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06250816 |
| Other study ID # |
2023-28/21 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2024 |
| Est. completion date |
February 1, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Uludag University |
| Contact |
Leman Gökçenur Aydin, MD |
| Phone |
+905532043332 |
| Email |
lgaydin[@]uludag.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The operating room environment can be frightening for pediatric patients. Many techniques
have been used to make the operating room environment less intimidating, including allowing
parents to accompany part of this procedure, play therapy and various distraction strategies
during the entrance to the operating room. In a survey study, it was reported that parents
were expected to create hospital conditions with a more child-friendly atmosphere. In this
context, it is thought that creating a warmer environment for children, including the clothes
worn in the operating room, may reduce the anxiety level of children. In this study,
investigators' aim was to investigate the effect of wearing an hospital gown with cartoon
characters on the reduction of preoperative anxiety in children scheduled for Orthopedic
surgery by in the operating room.
Description:
Pediatric patients aged between 4-12 years, who are planned to be operated by the Orthopedic
Surgery Clinic in Bursa Uludag University Faculty of Medicine Hospital Surgical Theatre, will
be randomized preoperatively by closed envelope method. One group will have a preoperative
visit, the investigator will meet the patient and assess the child's anxiety level using the
modified Yale Preoperative Anxiety Scale (m-YPAS). Afterwards, the patient will be asked to
choose one of the hospital gowns they want to wear and put it on with parental assistance.
The other group also will have a preoperative visit, the investigator will meet the patient
and assess the child's anxiety level using m-YPAS. The patient will be asked to wear the
hospital gown used in the hospital in routine practice with parental assistance. Then the
patients will be taken to the operating room as in the routine procedure. Before induction of
anesthesia in the operating room, another investigator will re-evaluate the child's anxiety
level using the m-YPAS scale. Vital signs, analgesic use and duration of surgery will be
recorded during the operation. Afterwards, the satisfaction level of the parents will be
evaluated.
