FatigueVRfatigueNCT05774379
Virtual Reality and Fatigue Education
A study testing virtual reality and fatigue education and fatigue education in people with Fatigue and Anxiety, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
It was planned to evaluate the effect of distraction intervention with virtual reality and fatigue education on the level of fatigue and anxiety in children with cancer. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- What is being tested?
- virtual reality and fatigue education and fatigue education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 10 Feb 2023
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be between 7-18 years old
- Inpatient chemotherapy treatment for more than three days
- 4 weeks over the time of diagnosis (not in the induction phase)
- Having a hemoglobin level above the criteria for transfusion of blood products (8 mg/dl for hematological malignancies, below 7 mg/dl for oncological malignancies).
- The child voluntarily agrees to participate in the study and consent is obtained from the child and parent
Who cannot join
- Being in terminal period
- undergoing a surgical operation
- Unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality and Fatigue Education on Fatigue and Anxiety Levels in Children With Cancer
It was planned to evaluate the effect of distraction intervention with virtual reality and fatigue education on the level of fatigue and anxiety in children with cancer.
Read the detailed description
H1: The fatigue scores of the patients who received distraction intervention with virtual reality and were given fatigue training were lower than the group that was given only fatigue training.
H2: The anxiety scores of the patients who received distraction intervention with virtual reality and were given fatigue training were lower than the group that was given only fatigue training.
Data collection After the child and his family are informed about the study, their written informed consent will be obtained. All children included in the study on the day (day 0) prior to the start of chemotherapy treatment will be given training on fatigue. In order to determine how he felt and his level of fatigue on the day of the training, it was planned to apply the Child Anxiety Scale-State (CAS-D), Child Fatigue Scale-24 Hours and Visual Fatigue Scale at 16.00 (pretest).
After randomization is achieved, a distraction intervention will be applied once a day for 10-15 minutes with virtual glasses on the 1st, 2nd and 3rd days of the chemotherapy treatment of the children in the study group. This intervention is planned to take place between 14.00-15.00 in the afternoon.
- Being tested
- virtual reality and fatigue education, fatigue education
- Keywords
- virtual reality
- Medical subject headings
- Fatigue, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality and fatigue educationDevice
virtual reality distraction for 3 days and fatigue education for children
fatigue educationBehavioural
fatigue education for children
| Study group | Role | What they receive |
|---|---|---|
| virtual reality and fatigue education | Experimental | watching the application by wearing virtual glasses for 3 days and Providing training on fatigue to all children (1 session, average 45 minutes) (using role-play, exercise, games, coloring books and activity materials) Receives: Device: virtual reality and fatigue education |
| fatigue education | Experimental | Providing training on fatigue to all children (1 session, average 45 minutes) (using role-play, exercise, games, coloring books and activity materials) Receives: Behavioral: fatigue education |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue
Child Fatigue Scale-24 Hours: It consists of 10 items related to the perception of fatigue in children with cancer. The items in the scale contain statements that will show the child's experience of fatigue-related symptoms in the last 24 hours. The items were arranged according to likert scoring between 'never (1)' and 'a lot (5)'.
Measured: pretest, 1., 2. and 3. days of chemotheraphy
anxiety
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety
Measured: pretest, 1., 2. and 3. days of chemotheraphy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Apr 2022
- Primary completion1 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gülçin Özalp Gerçeker, pHD, RN, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774379
- Sponsor's protocol ID
- 5776GOA
- Acronym
- VRfatigue
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality and Fatigue Education on Fatigue and Anxiety Levels in Children With Cancer
- ClinicalTrials.gov ID
- NCT05774379
- Acronym / sponsor ID
- VRfatigue / 5776GOA
- Keywords
- virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 17 Mar 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.
It was planned to evaluate the effect of distraction intervention with virtual reality and fatigue education on the level of fatigue and anxiety in children with cancer.
Detailed description
H1: The fatigue scores of the patients who received distraction intervention with virtual reality and were given fatigue training were lower than the group that was given only fatigue training.
H2: The anxiety scores of the patients who received distraction intervention with virtual reality and were given fatigue training were lower than the group that was given only fatigue training.
Data collection After the child and his family are informed about the study, their written informed consent will be obtained. All children included in the study on the day (day 0) prior to the start of chemotherapy treatment will be given training on fatigue. In order to determine how he felt and his level of fatigue on the day of the training, it was planned to apply the Child Anxiety Scale-State (CAS-D), Child Fatigue Scale-24 Hours and Visual Fatigue Scale at 16.00 (pretest).
After randomization is achieved, a distraction intervention will be applied once a day for 10-15 minutes with virtual glasses on the 1st, 2nd and 3rd days of the chemotherapy treatment of the children in the study group. This intervention is planned to take place between 14.00-15.00 in the afternoon.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality and fatigue education | Experimental | Device: virtual reality and fatigue educationwatching the application by wearing virtual glasses for 3 days and Providing training on fatigue to all children (1 session, average 45 minutes) (using role-play, exercise, games, coloring books and activity materials) |
| fatigue education | Experimental | Behavioral: fatigue educationProviding training on fatigue to all children (1 session, average 45 minutes) (using role-play, exercise, games, coloring books and activity materials) |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Be between 7-18 years old
- Inpatient chemotherapy treatment for more than three days
- 4 weeks over the time of diagnosis (not in the induction phase)
- Having a hemoglobin level above the criteria for transfusion of blood products (8 mg/dl for hematological malignancies, below 7 mg/dl for oncological malignancies).
- The child voluntarily agrees to participate in the study and consent is obtained from the child and parent
Key exclusion criteria (3 listed)
- Being in terminal period
- undergoing a surgical operation
- Unwillingness to participate in the study
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 and fatigue educationvirtual reality distraction for 3 days and fatigue education for children | Device | virtual reality and fatigue education |
| fatigue educationfatigue education for children | Behavioural | fatigue education |
Primary outcome
fatigue
Time frame: pretest, 1., 2. and 3. days of chemotheraphy
Child Fatigue Scale-24 Hours: It consists of 10 items related to the perception of fatigue in children with cancer. The items in the scale contain statements that will show the child's experience of fatigue-related symptoms in the last 24 hours. The items were arranged according to likert scoring between 'never (1)' and 'a lot (5)'.
anxiety
Time frame: pretest, 1., 2. and 3. days of chemotheraphy
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety
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 17 Mar 2023.
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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.
Gülçin Özalp Gerçeker, pHD, RN principal investigator
Dokuz Eylul University
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 and fatigue education and fatigue education in people with Fatigue and Anxiety, run by Dokuz Eylul 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 5 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: finished, as of the sponsor's last update on 17 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?
fatigue (time frame: pretest, 1., 2. and 3. days of chemotheraphy). 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 17 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.