Gynecologic CancersNCT06760689
Brief Title- Virtual Reality Glasses in Gynecologic Cancer
A study testing virtual reality glasses and scale in people with Gynecologic Cancers and Anxiety, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
It was planned to determine the effect of virtual reality glasses used in female patients diagnosed with gynecological cancer and receiving chemotherapy on treatment compliance and anxiety level. The study has a single-center, randomized controlled experimental design. 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
- Gynecologic Cancers, Anxiety
- What is being tested?
- virtual reality glasses and scale
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Being over 18 years old.
- Stage 1-2-3
- Knowing the disease diagnosis
- Knowing how to read and write in Turkish
- No history of seizures
- No cranial metastasis
Show all 11Show fewer
- Not diagnosed with a psychiatric disorder, no dementia
- Those who receive their treatment in 21-day periods to ensure equality in application frequencies
- Able to use virtual reality glasses
- No visual or hearing impairment
- Volunteer patients
Who cannot join
- Stage 4
- Those with vertigo
- Those with hyperemesis during pregnancy
- Those who experience nausea and vomiting during travel
- Those with visual and hearing impairment
- Patients who do not know their cancer diagnosis, have been diagnosed with cancer but have not received treatment or have completed their cure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Etlik Şehir Hastanesi
Ankara, Yenimahalle, 06600
About this study
Official title: The Effect of Virtual Reality Glasses Used in Gynecologic Cancer Patients Receiving Chemotherapy on Treatment Compliance and Anxiety Level.
It was planned to determine the effect of virtual reality glasses used in female patients diagnosed with gynecological cancer and receiving chemotherapy on treatment compliance and anxiety level. The study has a single-center, randomized controlled experimental design.
Read the detailed description
When cancer is diagnosed, a process of uncertainty begins for the individual. When an individual associates their illness with death, they often consider the situation to be frightening, painful, complex, and ambiguous, which can lead to mental confusion. ). In these emotional fluctuations, studies have revealed that a large proportion of patients experience various mental problems such as anxiety and anxiety disorders, coordination disorders and adherence to treatment, both due to the burden of the disease and the side effects of treatment. Emotional negativities felt by the patient may cause the recovery process to be prolonged, the quality of life to decrease, and the length of hospital stay to increase when in a hospital environment. In order to prevent such negativities, it is very important to identify the symptoms of anxiety and depression in cancer patients at an early stage and to initiate appropriate treatments. The development and application of the latest technology in the field of health offers new and non-invasive approaches to cancer-related symptom management. Virtual reality (SG), a new era in the management of symptoms, is the combination of fiction, imagination and reality, which is capable of real reflective animation at the same time under the control of many devices. Virtual reality (SG), a new era in the management of symptoms, is the combination of fiction, imagination and reality, which is capable of real reflective animation at the same time under the control of many devices.In a clinical study, it was concluded that distracting videos (tennis, boxing video, etc.) watched with virtual reality glasses had a beneficial therapeutic effect on edema.As a result of the one-week virtual reality application awareness training conducted on 50 women with ovarian cancer who experienced anxiety, depression and cancer-related fatigue during chemotherapy in Beijing, China, it was recorded that these symptoms improved significantly.When the literature was reviewed, it was predicted that the application of virtual reality glasses in cancer patients in our country was limited, and this study was planned to determine the effect of virtual reality glasses used in female patients diagnosed with gynecological cancer and receiving chemotherapy on the level of compliance and anxiety.
- Conditions
- Gynecologic Cancers, Anxiety
- Being tested
- virtual reality glasses, scale
- Keywords
- Anxiety, chemotherapy, Gynecological cancer, Virtual reality, Adherence to treatment, rastgele kontrollü deneme
- Medical subject headings
- Anxiety Disorders, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesDevice
One of the videos chosen by the patient will be opened in the virtual reality glasses and will be played for 20 minutes.
scaleOther
The patient received standard nursing care. Scales were filled in after the course.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The patient was given detailed information about the research and intervention, and written consent was obtained with an informed voluntary consent form. The patient's information was obtained through the descriptive information form containing sociodemographic information.The same ways were applied for 1,2,3 cures. The researcher applied the pre-test State and Trait Anxiety Scale, and the Chronic Disease Adaptation Scale (CHSS) to the patient.The patient was directed to move to the room designated by the nurse in the outpatient unit. Before the chemotherapy course began, the patient was shown the content that the patient could watch through virtual reality glasses on the phone.He was asked to choose one of them.The patient watched a video of his/her choice with the virtual reality glasses application (20 min). At the end, the glasses were removed. Afterwards, the State and Trait Anxiety Scale and the Chronic Diseases Adjustment Scale (CHAS) were applied. Receives: Device: virtual reality glasses; Other: scale |
| control group | Active comparator | The pre-test State and Trait Anxiety Scale and Chronic Disease Adjustment Scale (CHAS) were applied to the patient by the researcher.
The patient was directed to the room determined by the nurse in the outpatient treatment unit.
The patient's chemotherapy infusion started.The patient received standard nursing care. After 30 minutes, the State and Trait Anxiety Scale and the Chronic Diseases Adjustment Scale (CHAS) were administered. Receives: Other: scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Virtual Reality Glasses on Treatment Adherence and Anxiety Levels in Gynecological Cancer Patients Receiving Chemotherapy.
59 experimental groups of female patients in the outpatient chemotherapy unit will be shown a video of their choice, such as nature, underwater, or forest walk, placed in virtual reality glasses, taking into account the inclusion and exclusion criteria. Questions on two scales will be asked before and after this viewing. For the control group of 59 people, the same questions on two scales will be asked before and after chemotherapy without any intervention.
Measured: 20 weeks
State and trait anxiety scale
This scale consists of two sub-dimensions, each consisting of 20 items, and contains a total of 40 items. The sub-scales are called "State Anxiety Scale" and "Trait Anxiety Scale". The first 20 items evaluate the emotional experiences of the individual in a certain situation. The emotions of the participants are expressed with the specific features of (1) None, (2) A Little, (3) A Lot, and (4) Completely. The items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 in the State Anxiety Scale consist of translated expressions. These scores are translated in return (1=4, 2=3, 3=2, 4=1). Others represent correct objects. The state anxiety score varies between 20 and 80 in total, and reflects personal anxiety rates. High scores indicate high anxiety levels, and low scores indicate low anxiety levels.
Measured: 20 weeks
Chronic Disease Adjustment Scale
It is a scale used to evaluate the adaptation level of patients with chronic diseases. This scale, which consists of three subdimensions and 25 items, measures physical adaptation with items 1, 9, 10, 13, 14, 15, 16, 18, 22, 23, and 24 (maximum 55, minimum 11 points), social adaptation with items 2, 3, 5, 7, 17, 19, and 25 (maximum 35, minimum 7 points) and psychological adaptation with items 4, 6, 8, 11, 12, 20, and 21 (maximum 35, minimum 7 points). The total score obtained from the scale is 125. High scores obtained from the subdimensions or the entire scale indicate that the patients' adaptation level to the disease is high.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Dec 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancersStudies of the same condition, open and under way.
- 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
- The study has a single-center, randomized controlled experimental design. It includes the experimental and control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Önder, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760689
- Sponsor's protocol ID
- CAKU-HEM-BO-01
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Used in Gynecologic Cancer Patients Receiving Chemotherapy on Treatment Compliance and Anxiety Level.
- ClinicalTrials.gov ID
- NCT06760689
- Acronym / sponsor ID
- CAKU-HEM-BO-01
- Conditions
- Gynecologic Cancers, Anxiety
- Keywords
- Anxiety, chemotherapy, Gynecological cancer, Virtual reality, Adherence to treatment, rastgele kontrollü deneme
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 7 Jan 2025 (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 planned to determine the effect of virtual reality glasses used in female patients diagnosed with gynecological cancer and receiving chemotherapy on treatment compliance and anxiety level. The study has a single-center, randomized controlled experimental design.
Detailed description
When cancer is diagnosed, a process of uncertainty begins for the individual. When an individual associates their illness with death, they often consider the situation to be frightening, painful, complex, and ambiguous, which can lead to mental confusion. ). In these emotional fluctuations, studies have revealed that a large proportion of patients experience various mental problems such as anxiety and anxiety disorders, coordination disorders and adherence to treatment, both due to the burden of the disease and the side effects of treatment. Emotional negativities felt by the patient may cause the recovery process to be prolonged, the quality of life to decrease, and the length of hospital stay to increase when in a hospital environment. In order to prevent such negativities, it is very important to identify the symptoms of anxiety and depression in cancer patients at an early stage and to initiate appropriate treatments. The development and application of the latest technology in the field of health offers new and non-invasive approaches to cancer-related symptom management. Virtual reality (SG), a new era in the management of symptoms, is the combination of fiction, imagination and reality, which is capable of real reflective animation at the same time under the control of many devices. Virtual reality (SG), a new era in the management of symptoms, is the combination of fiction, imagination and reality, which is capable of real reflective animation at the same time under the control of many devices.In a clinical study, it was concluded that distracting videos (tennis, boxing video, etc.) watched with virtual reality glasses had a beneficial therapeutic effect on edema.As a result of the one-week virtual reality application awareness training conducted on 50 women with ovarian cancer who experienced anxiety, depression and cancer-related fatigue during chemotherapy in Beijing, China, it was recorded that these symptoms improved significantly.When the literature was reviewed, it was predicted that the application of virtual reality glasses in cancer patients in our country was limited, and this study was planned to determine the effect of virtual reality glasses used in female patients diagnosed with gynecological cancer and receiving chemotherapy on the level of compliance and anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study has a single-center, randomized controlled experimental design. It includes the experimental and control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: virtual reality glasses, Other: scaleThe patient was given detailed information about the research and intervention, and written consent was obtained with an informed voluntary consent form. The patient's information was obtained through the descriptive information form containing sociodemographic information.The same ways were applied for 1,2,3 cures. The researcher applied the pre-test State and Trait Anxiety Scale, and the Chronic Disease Adaptation Scale (CHSS) to the patient.The patient was directed to move to the room designated by the nurse in the outpatient unit. Before the chemotherapy course began, the patient was shown the content that the patient could watch through virtual reality glasses on the phone.He was asked to choose one of them.The patient watched a video of his/her choice with the virtual reality glasses application (20 min). At the end, the glasses were removed. Afterwards, the State and Trait Anxiety Scale and the Chronic Diseases Adjustment Scale (CHAS) were applied. |
| control group | Active comparator | Other: scaleThe pre-test State and Trait Anxiety Scale and Chronic Disease Adjustment Scale (CHAS) were applied to the patient by the researcher. The patient was directed to the room determined by the nurse in the outpatient treatment unit. The patient's chemotherapy infusion started.The patient received standard nursing care. After 30 minutes, the State and Trait Anxiety Scale and the Chronic Diseases Adjustment Scale (CHAS) were administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Being over 18 years old.
- Stage 1-2-3
- Knowing the disease diagnosis
- Knowing how to read and write in Turkish
- No history of seizures
Key exclusion criteria (6 listed)
- Stage 4
- Those with vertigo
- Those with hyperemesis during pregnancy
- Those who experience nausea and vomiting during travel
- Those with visual and hearing impairment
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 glassesOne of the videos chosen by the patient will be opened in the virtual reality glasses and will be played for 20 minutes. | Device | Experimental group |
| scaleThe patient received standard nursing care. Scales were filled in after the course. | Other | Experimental group, control group |
Primary outcome
Effect of Virtual Reality Glasses on Treatment Adherence and Anxiety Levels in Gynecological Cancer Patients Receiving Chemotherapy.
Time frame: 20 weeks
59 experimental groups of female patients in the outpatient chemotherapy unit will be shown a video of their choice, such as nature, underwater, or forest walk, placed in virtual reality glasses, taking into account the inclusion and exclusion criteria. Questions on two scales will be asked before and after this viewing. For the control group of 59 people, the same questions on two scales will be asked before and after chemotherapy without any intervention.
State and trait anxiety scale
Time frame: 20 weeks
This scale consists of two sub-dimensions, each consisting of 20 items, and contains a total of 40 items. The sub-scales are called "State Anxiety Scale" and "Trait Anxiety Scale". The first 20 items evaluate the emotional experiences of the individual in a certain situation. The emotions of the participants are expressed with the specific features of (1) None, (2) A Little, (3) A Lot, and (4) Completely. The items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 in the State Anxiety Scale consist of translated expressions. These scores are translated in return (1=4, 2=3, 3=2, 4=1). Others represent correct objects. The state anxiety score varies between 20 and 80 in total, and reflects personal anxiety rates. High scores indicate high anxiety levels, and low scores indicate low anxiety levels.
Chronic Disease Adjustment Scale
Time frame: 20 weeks
It is a scale used to evaluate the adaptation level of patients with chronic diseases. This scale, which consists of three subdimensions and 25 items, measures physical adaptation with items 1, 9, 10, 13, 14, 15, 16, 18, 22, 23, and 24 (maximum 55, minimum 11 points), social adaptation with items 2, 3, 5, 7, 17, 19, and 25 (maximum 35, minimum 7 points) and psychological adaptation with items 4, 6, 8, 11, 12, 20, and 21 (maximum 35, minimum 7 points). The total score obtained from the scale is 125. High scores obtained from the subdimensions or the entire scale indicate that the patients' adaptation level to the disease is high.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and scale in people with Gynecologic Cancers and Anxiety, run by Çankırı Karatekin 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 11 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: enrolling by invitation, as of the sponsor's last update on 7 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Effect of Virtual Reality Glasses on Treatment Adherence and Anxiety Levels in Gynecological Cancer Patients Receiving Chemotherapy. (time frame: 20 weeks). The study lists 3 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 7 Jan 2025.