Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05693584 |
| Other study ID # |
fbu_nurs_elmali_001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
November 1, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Fenerbahce University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Hemodialysis; It is the process of returning the liquid and solute content of the blood taken
from the patient to the patient as a result of rearrangement by means of a membrane and with
the help of a machine. A permanent vascular access that can be used for months or years is
required for HD treatment to be sufficient for patients with end-stage renal disease to
survive and improve their quality of life. For this reason, patients who will be treated for
HD need to have an arterio-venous fistula (AVF), graft or catheter to ensure adequate blood
flow. CRF patients treated with HD are exposed to 300-320 AVF cannulations per year on
average. The size and length of the diameter of the fistula needles, the piercing process
created in the skin, the advancement of the needles into the tissue during the procedure, the
entry angle of the needles and the entry techniques cause the patients to experience pain
during the procedure.
Non-pharmacological methods frequently used in pain control include many applications such as
distraction, massage, hot and cold application, aromatherapy.
Distraction, which is one of the non-pharmacological methods, is a method that enables
patients to focus their attention on a different point and to control and reduce the symptoms
they experience. Methods such as listening to music, taking pictures, watching television,
solving puzzles, daydreaming, deep breathing and coughing exercises, sphygmomanometer
blowing, active listening, tapping, inflating balloons, distraction cards and using virtual
reality glasses are used for this purpose.
With the virtual reality glasses, the individual gets away from the environment with the
glasses connected to the device worn on his head and the sounds coming from the headset,
concentrates his attention on the image he watches and feels like he is in another world
thanks to these five-dimensional glasses. The most basic feature that distinguishes virtual
reality glasses from similar applications is that it gives people a real feeling. Virtual
reality glasses, which are easy to apply and use, have no side effects, and can be effective
in physical, psychological and social recovery, are an initiative that can be preferred in
health applications.
In this study, it is aimed to determine the effect of using virtual reality glasses on pain
during fistula cannulation applied to hemodialysis patients.
The hypotheses of the research; Hâ‚€: The use of virtual reality glasses is not effective in
reducing the severity of pain.
H1: The use of virtual reality glasses reduces the severity of pain.
Description:
The research was carried out with patients in the hemodialysis unit of a private hospital in
Istanbul, between September and November 2022.The study had a pre-test post-test design and
was a single-center, parallel-design, randomized controlled experimental study.
Priori Power Analysis was performed to determine the sample size and Cohen's standard effect
size reference method was chosen accordingly. Considering 85% power, 0.005 significance
level, and 0.8 effect size for the study, the minimum required sample size was calculated as
23 for each group. Since it was thought that there might be data loss, it was decided to
include 28 patients in each group and 56 patients in total.
Computer-assisted simple randomization (https://www.randomizer.org/) was used to determine
the groups. There wasn't any blocking in this simple randomization. There wasn't any blinding
for the patients or the researchers throughout the study. Pain assessments were made by the
service nurses, and virtual reality glasses were applied by the researcher. The data were
collected by one researcher and the analysis and evaluations were made by the other
researcher. Thus, blanking was used during data collection and analysis.
The population of the study consists of patients (n=82) in the hemodialysis unit of a private
hospital in Istanbul, and the sample consists of patients who meet the research criteria and
agree to participate in the study (n=47).
In data collection; Introductory Information Form and Visual Analog Scale (Visual Comparison
Scale) (VAS) were used.
Virtual reality glasses: Bobo VR Z4 brand virtual reality glasses with 5.7 inch 1440x2560
pixel screen resolution and JBL brand wireless headset were used.
In this study, it is planned to analyze the data in SPSS program. Normality tests, mean,
standard deviation, minimum, maximum, number-percentage distributions in data analysis;
Independent Groups t-test, Mann Whitney U test, One-Way Analysis of Variance, Kruskal-Wallis
test will be used. Differences between groups in terms of categorical variables will be
examined with the chi-square test. Pearson correlation analysis will be used to examine the
relationships between variables, and Cohen-d effect size will be used to determine the effect
size.
