Clinical trial NCT05168696: The Effect of Virtual Reality on Anxiety and Fatigue in Women With Breast Cancer Receiving Adjuvant Chemotherapy
Official title: The Effect of Virtual Reality Glasses Application on Anxiety and Fatigue in Women With Breast Cancer Receiving Adjuvant Chemotherapy: Pretest-Posttest Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Anxiety
Fatigue
Keywords: Virtual reality
Distraction
Anxiety
Fatigue
Nursing
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Those between the ages of 18 - 65
* Those who are women
* Those who were diagnosed with breast cancer for the first time and received adjuvant chemotherapy treatment
* Patients receiving the protocol with Cyclophosphamide, Doxorubicin (Adriamycin)
* Those who know that they have breast cancer
* Those with the least education level who are literate
* Those who agreed to participate in the study
* Those who speak and understand Turkish

Exclusion Criteria:

* Those receiving neoadjuvant chemotherapy treatment
* Those with metastases
* Recurrent (Recurrent) ones
* Those who use psychiatric drugs
* Those with a history of seizures
* Those with communication problems (hearing, seeing, speaking, etc.)

Primary outcomes:
measure: State Anxiety Scale
timeFrame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
measure: Cancer Fatigue Scale
timeFrame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Secondary outcomes:
measure: Cancer Fatigue Scale
timeFrame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
measure: Cancer Fatigue Scale
timeFrame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
measure: Cancer Fatigue Scale
timeFrame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Other outcomes:
Locations:
city: Meram
country: Turkey
facility: Necmettin Erbakan University of Nursing Faculty
state: Konya
Study officials:
affiliation: Necmettin Erbakan University Faculty of Nursing
name: Arzu USLU, RN, MS, PhD(c), Instructor
role: STUDY_DIRECTOR
affiliation: Necmettin Erbakan University Faculty of Nursing
name: Selda ARSLAN, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: