AnxietyNCT06474780
Evaluation of The Effect of Virtual Reality Glasses
An observational study of Anxiety and Cancer, run by Gozde Oz.
Trial summary
The study was planned as a randomized controlled study to evaluate the effect of virtual reality glasses used on anxiety and treatment compliance in outpatient cancer patients receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 42 to 62 years
- Conditions the study is for
- Anxiety, Cancer, Chemotherapy
- What is being tested?
- Weight: 414g Size: 19.5cm x 14cm x 11cm Compatibility: Android and iOS VR Box 3.0 3D Virtual Reality Glasses Has the Feature of Fixation with Headband It has a lens mechanism tha
- Type of treatment
- Medical device
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2024to 25 Aug 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 42 to 62 years
- All sexes
- No healthy volunteers
- Adult
Study population: The population of the research consists of all individuals diagnosed with cancer who applied to a University Training and Research Hospital Outpatient Chemotherapy Unit to receive chemotherapy treatment. An average of 900 patients diagnosed with cancer are admitted to the chemotherapy unit per month. Power analysis was performed to determine the number of samples for this research. G*Power 3.1 program was used for power analysis. In determining the power of the research, it was aimed to reach a total of 30 people, 15 people in each group, with a 95% confidence level (significance level) and an effect size of 0.90. This sample size is at an appropriate level in terms of achieving the purpose of the research and strengthening its results. Therefore, it was decided to include 15 patients in the experimental group, 15 in the control group, and 30 patients in total.
Who may be able to join
- Being over 18 years old
- Knowing Turkish, agreeing to participate in the research
- Being diagnosed with cancer, regardless of the type of cancer
- Starting an intravenous chemotherapy treatment regimen after diagnosis
- Those who receive their treatment in 21-day periods to ensure equality in application frequencies.
- Able to use virtual reality glasses
- People without hearing or visual impairment are included
Who cannot join
- Anyone with any visual or hearing impairment
- The patient does not know the diagnosis of cancer, has been diagnosed with cancer but has not received treatment or has completed the cure.
- Those with brain tumor or brain metastasis are not included.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of The Effect of Virtual Reality Galsses Used on Anxiety and Threatment Compliance in Cancer Patients Receiving Outpatient Chemotherapy
The study was planned as a randomized controlled study to evaluate the effect of virtual reality glasses used on anxiety and treatment compliance in outpatient cancer patients receiving chemotherapy. The sample of the study consisted of a total of 30 patients, including 15 experimental and 15 control groups, who received intravenous chemotherapy treatment every 21 days between April 1 and September 31, 2023, in the outpatient chemotherapy unit of a research hospital. Research data will be collected using the Patient Information Form, Beck Anxiety Scale (BAI) and Chronic Disease Adaptation Scale (CCDS). In evaluating the data, it was planned to analyze the differences between the rates of categorical variables in independent groups with Chi-Square tests. It was planned to use t tests to compare quantitative continuous data between two independent groups. Dependent groups t-test will be used to compare measurements within groups. After being informed about the research, patients in both groups will be given a pre-test. Patients in the experimental group will be shown 3 different videos with virtual reality glasses during 3 cycles of chemotherapy treatment, and a final test will be administered to both groups at the end of the 3rd cycle..
- Conditions
- Anxiety, Cancer, Chemotherapy, Virtual Reality, Treatment Compliance
- Being tested
- Weight: 414g Size: 19.5cm x 14cm x 11cm Compatibility: Android and iOS VR Box 3.0 3D Virtual Reality Glasses Has the Feature of Fixation with Headband It has a lens mechanism tha
- Medical subject headings
- Anxiety Disorders, Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight: 414g Size: 19.5cm x 14cm x 11cm Compatibility: Android and iOS VR Box 3.0 3D Virtual Reality Glasses Has the Feature of Fixation with Headband It has a lens mechanism thaDevice
Patients in the experimental group were fitted with virtual reality glasses for 3 cycles and were allowed to watch videos of city tours, walks in the forest, and nature walks for 15 minutes, depending on their choice.
| Study group | Role | What they receive |
|---|---|---|
| experiment | Patients were informed about the study and patients who signed the informed consent form were included in the study. A pretest was applied to the patients. In the pre-test, data were collected using the "Patient Information Form", "Adaptation to Chronic Diseases Scale" and "Beck Anxiety Scale". Patients in the experimental group were shown videos of nature walks, forest walks and city tours of their choice for 15 minutes through virtual reality glasses 1 3 times in 21 days. At the end of the 3rd time, final tests were applied. Receives: Device: Weight: 414g Size: 19.5cm x 14cm x 11cm Compatibility: Android and iOS VR Box 3.0 3D Virtual Reality Glasses Has the Feature of Fixation with Headband It has a lens mechanism tha | |
| control | Patients were informed about the study and patients who signed the informed consent form were included in the study. A pretest was applied to the patients. In the pre-test, data were collected using the "Patient Information Form", "Adaptation to Chronic Diseases Scale" and "Beck Anxiety Scale". No application was made to the control group for 1.3 times in 21 days. Posttests were performed at the end of treatment for the third time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virtual Reality Glasses
Virtual Reality Glasses Used in Cancer Patients Will Reduce Anxiety Score on the Visual Analogue Scale in 3 Months
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start28 Jun 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion25 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gozde Oz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gozde Oz, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474780
- Sponsor's protocol ID
- 44.2023fbu
- Status last verified
- Jun 2024
- First submitted
- 24 May 2024
- Last updated
- 26 Jun 2024
- Results posted
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Virtual Reality Galsses Used on Anxiety and Threatment Compliance in Cancer Patients Receiving Outpatient Chemotherapy
- ClinicalTrials.gov ID
- NCT06474780
- Acronym / sponsor ID
- 44.2023fbu
- Conditions
- Anxiety, Cancer, Chemotherapy, Virtual Reality, Treatment Compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Gozde OzUniversity, hospital or other
- Study start
- 28 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 25 Aug 2024 (estimated)
- First posted
- 26 Jun 2024 (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.
The study was planned as a randomized controlled study to evaluate the effect of virtual reality glasses used on anxiety and treatment compliance in outpatient cancer patients receiving chemotherapy. The sample of the study consisted of a total of 30 patients, including 15 experimental and 15 control groups, who received intravenous chemotherapy treatment every 21 days between April 1 and September 31, 2023, in the outpatient chemotherapy unit of a research hospital. Research data will be collected using the Patient Information Form, Beck Anxiety Scale (BAI) and Chronic Disease Adaptation Scale (CCDS). In evaluating the data, it was planned to analyze the differences between the rates of categorical variables in independent groups with Chi-Square tests. It was planned to use t tests to compare quantitative continuous data between two independent groups. Dependent groups t-test will be used to compare measurements within groups. After being informed about the research, patients in both groups will be given a pre-test. Patients in the experimental group will be shown 3 different videos with virtual reality glasses during 3 cycles of chemotherapy treatment, and a final test will be administered to both groups at the end of the 3rd cycle..
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment | – | Device: Weight: 414g Size: 19.5cm x 14cm x 11cm Compatibility: Android and iOS VR Box 3.0 3D Virtual Reality Glasses Has the Feature of Fixation with Headband It has a lens mechanism thaPatients were informed about the study and patients who signed the informed consent form were included in the study. A pretest was applied to the patients. In the pre-test, data were collected using the "Patient Information Form", "Adaptation to Chronic Diseases Scale" and "Beck Anxiety Scale". Patients in the experimental group were shown videos of nature walks, forest walks and city tours of their choice for 15 minutes through virtual reality glasses 1 3 times in 21 days. At the end of the 3rd time, final tests were applied. |
| control | – | –Patients were informed about the study and patients who signed the informed consent form were included in the study. A pretest was applied to the patients. In the pre-test, data were collected using the "Patient Information Form", "Adaptation to Chronic Diseases Scale" and "Beck Anxiety Scale". No application was made to the control group for 1.3 times in 21 days. Posttests were performed at the end of treatment for the third time. |
Who may qualify
- Ages
- 42 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The population of the research consists of all individuals diagnosed with cancer who applied to a University Training and Research Hospital Outpatient Chemotherapy Unit to receive chemotherapy treatment. An average of 900 patients diagnosed with cancer are admitted to the chemotherapy unit per month. Power analysis was performed to determine the number of samples for this research. G*Power 3.1 program was used for power analysis. In determining the power of the research, it was aimed to reach a total of 30 people, 15 people in each group, with a 95% confidence level (significance level) and an effect size of 0.90. This sample size is at an appropriate level in terms of achieving the purpose of the research and strengthening its results. Therefore, it was decided to include 15 patients in the experimental group, 15 in the control group, and 30 patients in total.
Key inclusion criteria (7 listed)
- Being over 18 years old
- Knowing Turkish, agreeing to participate in the research
- Being diagnosed with cancer, regardless of the type of cancer
- Starting an intravenous chemotherapy treatment regimen after diagnosis
- Those who receive their treatment in 21-day periods to ensure equality in application frequencies.
Key exclusion criteria (3 listed)
- Anyone with any visual or hearing impairment
- The patient does not know the diagnosis of cancer, has been diagnosed with cancer but has not received treatment or has completed the cure.
- Those with brain tumor or brain metastasis are not included.
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 |
|---|---|---|
| Weight: 414g Size: 19.5cm x 14cm x 11cm Compatibility: Android and iOS VR Box 3.0 3D Virtual Reality Glasses Has the Feature of Fixation with Headband It has a lens mechanism thaPatients in the experimental group were fitted with virtual reality glasses for 3 cycles and were allowed to watch videos of city tours, walks in the forest, and nature walks for 15 minutes, depending on their choice. | Device | experiment |
Primary outcome
Virtual Reality Glasses
Time frame: 3 month
Virtual Reality Glasses Used in Cancer Patients Will Reduce Anxiety Score on the Visual Analogue Scale in 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Cancer, run by Gozde Oz.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GÖZDE ÖZ (05367022644, gozde_srdal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virtual Reality Glasses (time frame: 3 month). 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 26 Jun 2024.