Breast Cancer FemaleNCT05168696
The Effect of Virtual Reality on Anxiety and Fatigue in Women With Breast Cancer Receiving Adjuvant Chemotherapy
A study testing Virtual Reality Glasses in people with Breast Cancer Female and Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, Anxiety, Fatigue
- What is being tested?
- Virtual Reality Glasses
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University of Nursing Faculty
Meram, Konya, 42020
About this study
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
It was aimed to determine the effect of virtual reality glasses application on anxiety and fatigue in women with breast cancer receiving adjuvant chemotherapy.
Read the 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.
- Conditions
- Breast Cancer Female, Anxiety, Fatigue
- Being tested
- Virtual Reality Glasses
- Keywords
- Virtual reality, Distraction, Anxiety, Fatigue, Nursing
- Medical subject headings
- Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesOther
Virtual Reality Glasses
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality in Women with Breast Cancer | Experimental | It is planned to pre-test, wear virtual reality glasses and post-test before chemotherapy for breast cancer women who will receive adjuvant treatment for the first time, who agree to participate in the study. This follow-up will be done 3 more times, and each cure will be followed for 4 cures. It will be ensured that the patients fill out the State Anxiety Scale and Cancer Fatigue Scale as a pre-test and post-test. After the chemotherapy infusion starts, the patient will listen and watch the relaxing beach and nature content with 360 degrees for 30 minutes with virtual reality glasses attached to the patient. Receives: Other: Virtual Reality Glasses |
| Standard Care in Women with Breast Cancer | No intervention | Women with breast cancer who will receive adjuvant treatment for the first time, who agree to participate in the study, will be pre-tested before chemotherapy and a post-test will be performed 30 minutes after the start of chemotherapy treatment by the nurse. This follow-up will be done 3 more times, and each cure will be followed for 4 cures. It will be ensured that the patients fill out the State Anxiety Scale and Cancer Fatigue Scale as a pre-test and post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Scale
The mean anxiety scores of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 20 points and a maximum of 80 points are taken from the scale. The higher the score, the higher the anxiety.
Measured: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Cancer Fatigue Scale
The mean fatigue scores of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 15 points and a maximum of 60 points are taken from the scale. The higher the score, the higher the fatigue.
Measured: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Secondary outcomes (3)
Cancer Fatigue Scale
The physical function sub-dimension mean scores of fatigue of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 7 points and a maximum of 28 points are taken from the scale. As the score increases, physical fatigue increases.
Measured: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Cancer Fatigue Scale
The emotional function sub-dimension mean scores of fatigue of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 4 points and a maximum of 16 points are taken from the scale. Emotional fatigue increases as the score increases.
Measured: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Cancer Fatigue Scale
The cognitive function sub-dimension mean scores of fatigue of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 4 points and a maximum of 16 points are taken from the scale. As the score increases, cognitive fatigue increases.
Measured: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start4 Apr 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu USLU, Necmettin Erbakan University
- Investigators
- Arzu USLU, RN, MS, PhD(c), Instructor, Study director, Necmettin Erbakan University Faculty of NursingSelda ARSLAN, Assoc. Prof., Principal investigator, Necmettin Erbakan University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168696
- Sponsor's protocol ID
- 21149002
- Status last verified
- Mar 2023
- First submitted
- 9 Dec 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05168696
- Acronym / sponsor ID
- 21149002
- Conditions
- Breast Cancer Female, Anxiety, Fatigue
- Keywords
- Virtual reality, Distraction, Anxiety, Fatigue, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality in Women with Breast Cancer | Experimental | Other: Virtual Reality GlassesIt is planned to pre-test, wear virtual reality glasses and post-test before chemotherapy for breast cancer women who will receive adjuvant treatment for the first time, who agree to participate in the study. This follow-up will be done 3 more times, and each cure will be followed for 4 cures. It will be ensured that the patients fill out the State Anxiety Scale and Cancer Fatigue Scale as a pre-test and post-test. After the chemotherapy infusion starts, the patient will listen and watch the relaxing beach and nature content with 360 degrees for 30 minutes with virtual reality glasses attached to the patient. |
| Standard Care in Women with Breast Cancer | No intervention | –Women with breast cancer who will receive adjuvant treatment for the first time, who agree to participate in the study, will be pre-tested before chemotherapy and a post-test will be performed 30 minutes after the start of chemotherapy treatment by the nurse. This follow-up will be done 3 more times, and each cure will be followed for 4 cures. It will be ensured that the patients fill out the State Anxiety Scale and Cancer Fatigue Scale as a pre-test and post-test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Those receiving neoadjuvant chemotherapy treatment
- Those with metastases
- Recurrent (Recurrent) ones
- Those who use psychiatric drugs
- Those with a history of seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality GlassesVirtual Reality Glasses | Other | Virtual Reality in Women with Breast Cancer |
Primary outcome
State Anxiety Scale
Time frame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
The mean anxiety scores of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 20 points and a maximum of 80 points are taken from the scale. The higher the score, the higher the anxiety.
Cancer Fatigue Scale
Time frame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
The mean fatigue scores of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 15 points and a maximum of 60 points are taken from the scale. The higher the score, the higher the fatigue.
3 secondary outcomes
Cancer Fatigue Scale
Time frame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Cancer Fatigue Scale
Time frame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Cancer Fatigue Scale
Time frame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arzu USLU, RN, MS, PhD(c), Instructor study director
Necmettin Erbakan University Faculty of Nursing
Selda ARSLAN, Assoc. Prof. principal investigator
Necmettin Erbakan University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Glasses in people with Breast Cancer Female and Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Scale (time frame: 1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.