Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05168696 |
| Other study ID # |
21149002 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 4, 2022 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Necmettin Erbakan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It was aimed to determine the effect of virtual reality glasses application on anxiety and
fatigue in women with breast cancer receiving adjuvant chemotherapy.
Description:
The number of women with breast cancer worldwide is increasing day by day. Uncertainty of the
efficacy of treatment, difficulty in accepting the disease, financial difficulties, insomnia,
fear and anxiety about the future, concentration disorder, feeling angry, focusing on
thoughts of illness and death, irregularities in work and family life, emergence of treatment
Their quality of life is adversely affected due to many conditions such as worrying about
side effects and loss of appetite. The disease process should be managed correctly before
these symptoms related to treatment occur in patients. Anxiety and fatigue are the leading
symptoms that limit the activities of daily living and significantly affect the social lives
of patients receiving chemotherapy for the first time after the diagnosis of breast cancer.
46%-71% of patients diagnosed with cancer experience anxiety and 80%-90% fatigue during
chemotherapy. Nurses, who are health professionals, use non-pharmacological methods as well
as pharmacological methods in the prevention and management of symptoms during the
chemotherapy treatment process. Non-pharmacological methods include practices such as
meditation, yoga, hypnosis, prayer, relaxation techniques, daydreaming, and cognitive
behavioral therapies that involve distraction. With these cognitive behavioral therapies,
nurses aim to strengthen the self-care of cancer patients, increase adherence to the disease,
develop effective coping methods, manage chemotherapy-related side effects, and increase hope
and belief. With the method of distraction, which is frequently used from cognitive
behavioral therapies, it is aimed to focus on another stimulus and to get away from negative
feelings and thoughts. Recently, virtual reality application has been used frequently in the
field of health for the method of distraction. Virtual reality is defined as the human
computer interface that makes it feel as if it is in another universe with tools. The
three-dimensional screen provides the attention of the person with the virtual reality
stimuli with the motion detection system. The virtual reality application that attracts
attention is preferred because it is a non-invasive intervention, has an affordable cost, and
is effective in the motivation and well-being of the individual. In the meta-analysis of
cancer-related symptom management, virtual reality applications, which do not require any
special training, were found to increase tolerance to chemotherapy, to be effective in
symptom management, to increase quality of life, and to enable acceptance of chronic disease.
In the study, it was also stated that virtual reality applications were effective in reducing
anxiety, depression, pain and cognitive function symptoms, although not effective in reducing
fatigue, it was beneficial, and no serious side effects were reported. It is seen that the
studies were designed as a single-time measurement, non-randomized research design, and a
single-group pre-test-post-test. In this study, which aims to evaluate the effect of virtual
reality glasses application on anxiety and fatigue in women with breast cancer receiving
adjuvant chemotherapy, it is planned to increase the level of evidence of virtual reality
glasses application by making multiple measurements and to evaluate fatigue with physical,
emotional and cognitive sub-dimensions. In addition, this study is important in terms of
increasing the awareness of oncology nurses who care for breast cancer patients about virtual
reality application and integrating the method of distraction with virtual reality
application into standard care. It is thought that it is useful and appropriate for the nurse
to manage the distraction method with the virtual reality application, which is a
non-invasive intervention, does not require specific skills, and has no serious side effects.
For this purpose, it was planned to determine the effect of virtual reality glasses
application on anxiety and fatigue in women with breast cancer receiving adjuvant
chemotherapy.
