Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05893680 |
| Other study ID # |
1122 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 4, 2021 |
| Est. completion date |
April 5, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
Istanbul University - Cerrahpasa (IUC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The 3 non-pharmacological methods of online gaming, cold application, and placebo were chosen
to reduce postoperative pain in children undergoing orthopedic and traumatology surgery. The
effect of these 3 non-pharmacological methods on pain reduction was measured and compared.
Description:
This study was designed as a randomized controlled trial to compare the effects of cold
application, online gaming, and placebo on postoperative pain in children.
The sample size of the study was determined as 160 children, considering a 5% alpha error
rate, 90% power, and the probability of loss of data during data collection, using G*Power
program (3.1.9.2.) According to this result, the population of the study is planned to be
formed with 160 child patients, aged between 7-12, who are hospitalized in the Palace Lower
Floor Orthopedics Service of Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and
Research Hospital. The 160 children who make up the sample will be randomly assigned to
"online game and cold application", "online game", "cold application", and "placebo" groups,
previously sorted as group 1, group 2, group 3, and group 4 by the lottery method. In the
study, the intervention of the relevant group will be applied to each child during pain
control in each group.
A randomization list consisting of 40 blocks of four, based on age, gender, and the extremity
region where the operation was performed, was created (https://www.randomizer.org/#randomize)
to assign the children participating in the study to the groups randomly.
After the children were assigned to the intervention groups homogeneously and randomly, the
study was started.
Before applying any pain-reducing interventions to all children in all the intervention
groups, pain assessment was conducted using the visual analog scale (VAS) at 4 hours after
surgery. The child's parent was also asked to evaluate the child's pain independently using
the same scale. In this way, pre-intervention pain assessment was performed. Later, the
pain-reducing intervention specific to the group in which the child was randomized was
applied to the child.
The cold application group received a 20-minute application of cold gel that had been kept in
the freezer for at least 2 hours on the surgical site of the children.
The children in the online game group were allowed to play a game they knew and wanted to
play beforehand. This intervention lasted for 20 minutes.
The children in the group receiving both cold application and online game intervention were
provided with the opportunity to play a previously known and desired online game while
applying cold gel that had been kept in the freezer for at least 2 hours to the surgical site
for 20 minutes. The intervention lasted for 20 minutes.
The children in the placebo group were administered 2 ml dose of sterile %0.9 saline solution
(isotonic) intravenously. The mother and child were informed that the intervention
administered during the procedure was a pain reliever.
After starting the pain-reducing interventions in all groups, pain assessment using VAS was
repeated at 10 and 20 minutes with a double-blind technique by asking both the child and the
parent. The cold application and online game interventions were stopped after the pain
assessment at 20 minutes. Then, pain measurement with VAS was repeated at 40 minutes after
the start of the pain-reducing interventions, and the measurement results were recorded to
end the study.
In all groups, routine monitoring of fever, pulse, respiration, and saturation, which are
already part of the clinic's standard practice, has been performed.
The assumptions of parametric tests for the obtained data will be evaluated to determine the
appropriate statistical method, and data analysis will be performed. The results of the
analysis will be interpreted, and the relevant data will be recorded.
