Trial Title:
The Effect of Virtual Reality on Pain, Anxiety and Satisfaction Level Before Mammography
NCT ID:
NCT06265207
Condition:
Mammography
Early Diagnosis of Cancer
Conditions: Keywords:
Mammography
virtual reality
pain
anxiety
satisfaction
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Single Blind Parallel Group Randomized Controlled Trial
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Since the researcher will be conducting the research, blinding will not be possible, and
separate consent forms were prepared for the experimental and control groups, without
specifying which group they were in, and it was planned to blind the participants in this
way. In addition, in order to prevent statistical bias, it is planned to prevent bias in
data analysis by coding the data as first group and second group, rather than
experimental and control group, when entering the data into SPSS, and by not giving
information about which group is the experiment and which is the control group.
Intervention:
Intervention type:
Other
Intervention name:
Virtual reality
Description:
Before the mammography, a 20-minute relaxing video featuring nature and forest views will
be watched with VR SHINECON 360 degree glasses. Since it is seen in the literature that
watching a video for 20 minutes provides effective results, the video viewing time was
determined as 20 minutes.
Arm group label:
Experimental group
Intervention type:
Other
Intervention name:
routine maintenance
Description:
routine maintenance
Arm group label:
Control group
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Having applied for mammography for screening purposes,
- having no communication problems,
- being over 18 years of age,
- not having a history of breast cancer
- voluntarily agreeing to participate in the study
Exclusion Criteria:
- Being screened for breast cancer
- having vision or hearing problems
- being under 18 years of age.
Gender:
Female
Gender based:
Yes
Gender description:
Only female applicants will be included due to breast cancer screening.
Minimum age:
18 Years
Maximum age:
69 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cancer Early Diagnosis, Screening and Education Center Unit
Address:
City:
Kars
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
derya şimşekli, PhD
Phone:
05545965789
Email:
deryasimsekli95@gmail.com
Investigator:
Last name:
Gönül GÖKÇAY, PhD
Email:
Sub-Investigator
Start date:
February 15, 2024
Completion date:
September 27, 2024
Lead sponsor:
Agency:
Ardahan University
Agency class:
Other
Collaborator:
Agency:
Kafkas University
Agency class:
Other
Source:
Ardahan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06265207
