Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05319210 |
| Other study ID # |
188972 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
July 1, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Suleyman Demirel University |
| Contact |
Serife Tutar T Assistant professor, PhD |
| Phone |
+905053126429 |
| Email |
serifeguven[@]sdu.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this research; This is a randomized controlled experimental study planned to
examine the effect of virtual reality glasses and buzzy application on pain management during
venous catheter insertion in children.
Description:
The purpose of this research; This is a randomized controlled experimental study planned to
examine the effect of virtual reality glasses and buzzy application on pain management during
venous catheter insertion in children.
The universe of the research is all children between the ages of 7 and 12 who applied to
Hospital Emergency Service will be formed. G power analysis program was used to calculate the
sample size of the study. The number of samples was calculated according to 95% power, 0.05
margin of error and 0.80 effect size. It is envisaged that 36 children will be included in
the sample for each group. However, considering that sample losses may be experienced during
the process of the research, it is planned to include 40 participants (120 participants in
total) for each group.
"Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State
(CAS-D)" and Wong-Baker Faces Pain Scale will be used to collect research data.
In the collection of research data, first of all, patients will be divided into intervention
and control groups in accordance with the randomization scheme. Our research will consist of
two interventions (Buzzy device, virtual reality glasses) and a control group (routine
outpatient procedures).
Before the procedure; Written and verbal "Informed Consent" will be obtained from all
participants in the intervention and control groups. "Child and Parent Diagnosis Form",
"Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale
will be applied to the participants who agree to participate in the study.
Process Sequence and After; Venous catheter insertion will be done in line with the routine
practice of the outpatient clinic. Venous catheter placement in all children included in the
study will be performed by the researcher working in this one in order to keep the
practitioner-related factors under control. Children who cannot insert a venous catheter in a
single attempt will be excluded from the study.
Licensed SPSS (Statistical Package for the Social Science) 20.0 package program will be used
in the evaluation of the data. Descriptive analyzes such as number, percentage, frequency,
mean, standard deviation and percentile distributions will be used to evaluate the
characteristics of children. Nonparametric tests will be used according to the results of
normal distribution and homogeneity of variance. Mann Whitney U test, Wilcoxon test and
correlation analyzes will be used to evaluate the relationships between dependent and
independent variables. Results will be evaluated at 95% confidence interval and p<0.05
significance level.
