Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06265207 |
| Other study ID # |
ArdahanU-Simsekli-DS-02 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2024 |
| Est. completion date |
April 15, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Ardahan University |
| Contact |
Derya SIMSEKLI, Lecturer (MSc) |
| Phone |
05545965789 |
| Email |
deryasimsekli95[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, it is planned to determine the effect of virtual reality applied to women
before mammography on pain, anxiety and satisfaction levels. For this purpose, individuals
applying for breast cancer screening will first be randomly divided into experimental and
control groups. Pain, anxiety and satisfaction level evaluation forms will be applied to the
experimental group before the mammography procedure. A relaxing video will be watched with
virtual reality glasses and the mammography will be performed. At the end of the mammography,
the relevant forms will be applied to the individuals again. The control group will not be
subjected to any additional application that will continue with the applied routine.
Description:
Purpose and duration of the research: This research is to determine the effect of virtual
reality applied to women before mammography on the pain, anxiety and satisfaction levels.
Materials and methods of the research: This research is planned to be carried out in a
pre-test post-test single-blind randomized controlled experimental design.
Research Questions/Hypotheses:
Hypotheses of the Research H0: Virtual reality applied to women before mammography has no
effect on pain, anxiety and satisfaction levels.
H1a: Virtual reality applied to women before mammography has an effect on pain. H1b: Virtual
reality applied to women before mammography has an effect on anxiety.
H1c: Virtual reality applied to women before mammography has an effect on the satisfaction
level.
Dependent variables of the research; these are the scores to be taken from the Visual
Comparison Scale, State Anxiety Inventory and Satisfaction Rating Scale. The independent
variable of the research is; This is a video that will be watched with virtual reality
glasses.
The research was planned to be carried out in the Cancer Early Diagnosis, Screening and
Education Center (Ketem) unit. Individuals who applied to Kars Provincial Health Directorate
KETEM Unit during the research process will constitute the population of the research. A
power analysis was performed to determine the sample size of the study, and accordingly, with
a Cohen-d effect size of 0.80 (Goulet-Pelletier & Cousineau, 2018; Kilic, 2014), a power of
0.95, an alpha margin of error of 0.05, the minimum sample size planned to be included in the
study was 35 for the experimental group, It was determined that there should be a total of 70
participants, 35 in the control group. Considering the 10% loss, it is planned to include
four more patients in each group, making a total of 78 participants the sample of the study.
Randomization and blinding The block randomization method was chosen in the study to
eliminate selection bias and distribute participants equally to the groups. After determining
the participants who meet the inclusion and exclusion criteria, a pre-test was applied to
those who voluntarily agreed to participate, and then they will be randomized into
experimental and control groups. 78 participants who met the research criteria were assigned
to groups by block randomization. It will be decided which group is the experiment and which
group is the control, by a lottery drawn by a nurse independent of the study before the
implementation.
Descriptive Information Form, Visual Comparison Scale, State Anxiety Inventory and
Satisfaction Evaluation Scale will be used as data collection tools.Visual Comparison Scale;
It provides a simple assessment of pain. Pain is rated between mild pain = 0 and unbearable
pain = 10. Pain intensity is categorized as 1-3 mild, 4-6 moderate, and 7-10 severe.
State Anxiety Inventory; It was developed by Spielberger et al. to evaluate the anxiety level
of individuals. The scale measures trait and state anxiety. In this study, 20 items that
evaluate state anxiety will be used to evaluate state anxiety. The scale is scored in a
four-point Likert type, as "1 = not at all, 2 = a little, 3 = a lot and 4 = completely". The
score obtained shows the state anxiety score. The lowest score that can be obtained from the
scale is 20, while the highest score is 80. A high score indicates high anxiety, while a low
score indicates low anxiety level.
Satisfaction Evaluation Scale; It is a scale that individuals can easily understand and is
easy to apply. It is a scale indicated by a horizontal or vertical line, ranging from 0 = not
at all satisfied to 10 = quite satisfied. The evaluation is made based on the average value.
