Cancer PatientsNCT05884047
The Effect Of Virtual Reality Glasses On Vital Signs And State Anxiety Level In Cancer Patients
A study testing Virtual Glasses in people with Cancer Patients, run by Bahar İNKAYA at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a non-randomized control group experimental study to determine the effect of virtual reality glasses on vital signs and state anxiety levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Patients
- What is being tested?
- Virtual Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2020to 1 Jun 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with stage 1,2,3 cancer
- Receive radiotherapy and chemotherapy for the first time
- Volunteer patients who agreed to participate
Who cannot join
- -Patients outside the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Virtual Reality Glasses On Vital Signs And State Anxiety Level In Cancer Patients Receiving Chemotherapy For The First Time- Randomized Control Trial
This study was conducted as a non-randomized control group experimental study to determine the effect of virtual reality glasses on vital signs and state anxiety levels.
Read the detailed description
Purpose This study was conducted as a non-randomized control group experimental study to determine the effect of virtual reality glasses on vital signs and state anxiety levels in cancer patients receiving chemotherapy for the first time.
Methods and Sample The population of the study was composed of adult patients admitted to an oncology hospital in Ankara province with a diagnosis of stage I-II-III cancer to undergo chemotherapy treatment for the first time. The sample of the study consisted of 30 patients who were assigned to the intervention and control groups by the stratified sampling method (considering such characteristics as age, gender, marital status). The patient identification form, Spielberger state anxiety scale, patient opinion form, vital signs follow-up form, and virtual reality glasses were used to collect the data.
- Conditions
- Cancer Patients
- Being tested
- Virtual Glasses
- Keywords
- Chemotherapy, Virtually Reality, Anxiety, Nursing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual GlassesDevice
In the research, Samsung Gear VR SM-R323 brand and model SG glasses provided by the researcher were used. Patients were offered four different options to watch as "Forest of Serenity", "Calm Place", "Happy Place", "Gala 360 Travel \& Relax". Forest of Serenity is a nature video consisting of bird sounds, colorful trees and flowers, and a clear lake where fish can be seen swimming in it. Calm Place is a relaxing video where cycles are shown 24 hours a day, where a person finds himself by the lake in the forest in snowy, rainy sunny weather. In Happy Place, one finds himself in a virtual camp environment where natural events such as dynamically changing weather, day-night cycles, and falling stars are experienced. Gala 360 Travel \& Relax is a Paris-Notre Dame museum tour video.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glasses | Other | In the research, Samsung Gear VR SM-R323 brand and model SG glasses provided by the researcher were used. Patients were offered four different options to watch as "Forest of Serenity", "Calm Place", "Happy Place", "Gala 360 Travel \& Relax". Forest of Serenity is a nature video consisting of bird sounds, colorful trees and flowers, and a clear lake where fish can be seen swimming in it. Calm Place is a relaxing video where cycles are shown 24 hours a day, where a person finds himself by the lake in the forest in snowy, rainy sunny weather. In Happy Place, one finds himself in a virtual camp environment where natural events such as dynamically changing weather, day-night cycles, and falling stars are experienced. Gala 360 Travel \& Relax is a Paris-Notre Dame museum tour video. Receives: Device: Virtual Glasses |
| Scales | Other | Spielberger State Anxiety Inventory Vital Signs Follow-up Form Receives: Device: Virtual Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs- Blood pressure
Systolic blood pressure values
Measured: first measurement just before the start of the chemotherapy infusion
Vital signs-pulse
Pulse values
Measured: first measurement just before the start of the chemotherapy infusion
Vital signs- Blood pressure
Systolic blood pressure values
Measured: the last measurement just after the end of the chemotherapy infusion
Vital signs-pulse
Pulse values
Measured: the last measurement just after the end of the chemotherapy infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start27 Jan 2020
- Primary completion1 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies 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
- Semi-experimental
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahar İNKAYA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bahar İNKAYA, Ankara Yildirim Beyazıt University
- Investigators
- SEBILE OZDAG, Study chair, Hacettepe University Adult Oncology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884047
- Sponsor's protocol ID
- Ankara Yilidirim Beyazit Un.
- Status last verified
- May 2023
- First submitted
- 21 Jan 2022
- Last updated
- 1 Jun 2023
- 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 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Virtual Reality Glasses On Vital Signs And State Anxiety Level In Cancer Patients Receiving Chemotherapy For The First Time- Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05884047
- Acronym / sponsor ID
- Ankara Yilidirim Beyazit Un.
- Conditions
- Cancer Patients
- Keywords
- Chemotherapy, Virtually Reality, Anxiety, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bahar İNKAYAUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 1 Jun 2023 (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.
This study was conducted as a non-randomized control group experimental study to determine the effect of virtual reality glasses on vital signs and state anxiety levels.
Detailed description
Purpose This study was conducted as a non-randomized control group experimental study to determine the effect of virtual reality glasses on vital signs and state anxiety levels in cancer patients receiving chemotherapy for the first time.
Methods and Sample The population of the study was composed of adult patients admitted to an oncology hospital in Ankara province with a diagnosis of stage I-II-III cancer to undergo chemotherapy treatment for the first time. The sample of the study consisted of 30 patients who were assigned to the intervention and control groups by the stratified sampling method (considering such characteristics as age, gender, marital status). The patient identification form, Spielberger state anxiety scale, patient opinion form, vital signs follow-up form, and virtual reality glasses were used to collect the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Semi-experimental
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glasses | Other | Device: Virtual GlassesIn the research, Samsung Gear VR SM-R323 brand and model SG glasses provided by the researcher were used. Patients were offered four different options to watch as "Forest of Serenity", "Calm Place", "Happy Place", "Gala 360 Travel \& Relax". Forest of Serenity is a nature video consisting of bird sounds, colorful trees and flowers, and a clear lake where fish can be seen swimming in it. Calm Place is a relaxing video where cycles are shown 24 hours a day, where a person finds himself by the lake in the forest in snowy, rainy sunny weather. In Happy Place, one finds himself in a virtual camp environment where natural events such as dynamically changing weather, day-night cycles, and falling stars are experienced. Gala 360 Travel \& Relax is a Paris-Notre Dame museum tour video. |
| Scales | Other | Device: Virtual GlassesSpielberger State Anxiety Inventory Vital Signs Follow-up Form |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with stage 1,2,3 cancer
- Receive radiotherapy and chemotherapy for the first time
- Volunteer patients who agreed to participate
Key exclusion criteria (1 listed)
- -Patients outside the inclusion criteria
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 GlassesIn the research, Samsung Gear VR SM-R323 brand and model SG glasses provided by the researcher were used. Patients were offered four different options to watch as "Forest of Serenity", "Calm Place", "Happy Place", "Gala 360 Travel \& Relax". Forest of Serenity is a nature video consisting of bird sounds, colorful trees and flowers, and a clear lake where fish can be seen swimming in it. Calm Place is a relaxing video where cycles are shown 24 hours a day, where a person finds himself by the lake in the forest in snowy, rainy sunny weather. In Happy Place, one finds himself in a virtual camp environment where natural events such as dynamically changing weather, day-night cycles, and falling stars are experienced. Gala 360 Travel \& Relax is a Paris-Notre Dame museum tour video. | Device | Scales, Virtual reality glasses |
Primary outcome
Vital signs- Blood pressure
Time frame: first measurement just before the start of the chemotherapy infusion
Systolic blood pressure values
Vital signs-pulse
Time frame: first measurement just before the start of the chemotherapy infusion
Pulse values
Vital signs- Blood pressure
Time frame: the last measurement just after the end of the chemotherapy infusion
Systolic blood pressure values
Vital signs-pulse
Time frame: the last measurement just after the end of the chemotherapy infusion
Pulse values
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 1 Jun 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.
SEBILE OZDAG study chair
Hacettepe University Adult Oncology Hospital
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 Glasses in people with Cancer Patients, run by Bahar İNKAYA 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 3 inclusion and 1 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 1 Jun 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?
Vital signs- Blood pressure (time frame: first measurement just before the start of the chemotherapy infusion). The study lists 4 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 1 Jun 2023.