Nursing CariesNCT06074419
Effects of Virtual Reality on Sleep Quality and Mental Well-being
A study testing Occulus quest 2 virtual reality glasses in people with Nursing Caries, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
It is known that being in natural environments helps increase a person's well-being. It may not always be easy for individuals with neurological diseases to reach these environments due to their mobility limitations, other symptoms and other diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Occulus quest 2 virtual reality glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 20 Nov 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being diagnosed with multiple sclerosis (any type)
- Not being in an MS attack period
- Being between the ages of 18-80
- Having the level of awareness to maintain healthy communication
- Volunteering to participate in the study
Who cannot join
- Having impaired cognitive functions at a level that prevents maintaining healthy communication and responding to data collection forms.
- Being in an MS attack phase
- Being diagnosed with sleep apnea or any sleep disorder
- Using sleeping pills
- Having a major psychiatric disorder
- Working a night shift job
Show all 9Show fewer
- Having visual impairment
- Being younger than 18 or older than 80
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum Şehir Hastanesi
Erzurum, Karaman, (533) 935-2570
About this study
Official title: Evaluatıon Of The Effect Of The Use Of Vırtual Realıty Technology On Sleep Qualıty And Mental Well-Beıng In Multıple Sclerosıs Patıents
It is known that being in natural environments helps increase a person's well-being. It may not always be easy for individuals with neurological diseases to reach these environments due to their mobility limitations, other symptoms and other diseases. Virtual reality technology offers us unlimited opportunities to create these environments digitally and safely.
In this research, virtual nature videos will be watched using virtual reality glasses. This process will be done in the experimental group. In the control group, no action will be taken. The scores of the two groups will be compared.
The purpose of this presentation is to investigate whether virtual reality affects the mental well-being of beginners and the limits of sleep.
Read the detailed description
Multiple Sclerosis (MS) is an autoimmune, neurodegenerative disease characterized by demyelination and sclerotic plaques in the brain and spinal cord. Physical and psychological symptoms occur depending on the affected area. Environmental, viral, genetic and autoimmune factors are thought to play a role in the formation of MS disease, the etiology of which is still unknown. It ranks first among non-traumatic central nervous system diseases that cause disability in young adults. The disease is more common in women.
The disease is clinically seen in four types. These; relapsing-remitting (RRMS), primary progressive (PPMS), secondary progressive (SPMS) and relapsing progressive (RPMS) types.
A wide variety of symptoms occur in MS patients due to demyelination and inflammation. It causes loss of abilities such as motor disorders, cerebellar disorders, bladder-intestinal disorders, sensory disorders, cognitive disorders, emotional disorders and balance-coordination disorders. Apart from these, it has been shown that many social and psychological problems accompany these symptoms.
Mental disorders are more common in MS than in other neurological diseases. The resulting physical and mental disorders negatively affect the mental well-being of patients.
The risk of sleep problems is also increased in MS patients. It has been shown in the literature that MS patients have increased sleep problems compared to the general population and individuals with other chronic diseases. It has been reported that the incidence of sleep problems is between 25-54%. Controlling sleep problems of MS patients will improve their quality of life.
Virtual reality is alternative worlds in which a person can move as if he were living in any environment. In these virtual worlds, control is completely in the hands of the practitioners. For this reason, it allows the design of individual-specific environments and the application over and over again. Apart from that, it is a safe and interesting method. It is a method that can be applied with tools such as glasses, computers, headphones and sensors. Today, it is preferred in the treatment and rehabilitation of many neurological and chronic diseases.
There are different methods used to improve mental state and sleep quality in MS patients. This study will investigate whether the use of virtual reality glasses affects the mental well-being and sleep quality of patients.
- Conditions
- Nursing Caries
- Being tested
- Occulus quest 2 virtual reality glasses
- Keywords
- VİRTUAL REALİTY, SLEEP QUALITY, MENTAL WELL-BEING, MULTIPLE SCLEROSIS, NURSING
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Well-Being, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occulus quest 2 virtual reality glassesDevice
Patients will be shown nature videos via the specified virtual reality connection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Virtual reality glasses will be applied 2 days a week for 6 weeks. A sleep quality scale and a mental well-being scale will be applied before and after the procedure. Receives: Device: Occulus quest 2 virtual reality glasses |
| Control group | No intervention | There will be no virtual reality application. Sleep quality and mental well-being scale will be applied every 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index score
The scale evaluates sleep quality over the past 1 month. The first 19 questions are answered by the patient himself, and the last 5 questions are answered by the patient's relative or bed partner, making a total of 24 questions. The first 18 questions answered by the patient himself (self-assessment) are included in the scoring. The remaining 6 questions are used only for clinical information.
A score higher than five indicates that sleep quality is significantly inadequate.
The scores obtained after 6 weeks of proces will be analyzed. If sufficient power is not achieved as a result of the analysis, the number of samples will be increased.
Measured: 6 week
Warwick-Edinburgh Mental Well-Being Scale score
The scale covers subjective and psychological well-being states. The scale consists of 14 questions of five-point Likert type. There are no sub-dimensions in the scale. Participants answer the questions as 1: I completely disagree, 2: I disagree, 3: I somewhat agree, 4: I agree and 5: I completely agree. The lowest score from the scale is 14 and the highest score is 70. There are no reverse items in the scale. As the score obtained from the scale increases, the level of mental well-being also increases.The scores obtained after 6 weeks of proces will be analyzed. If sufficient power is not achieved as a result of the analysis, the number of samples will be increased.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Feb 2024
- Primary completion1 Sep 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- The experimental group will be shown a nature video through virtual reality glasses. No action will be applied to the control group. The two groups will be compared in terms of sleep quality and mental well-being
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Yağcı Karamanlı, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074419
- Sponsor's protocol ID
- haticeyagci
- Status last verified
- Jan 2025
- First submitted
- 2 Oct 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluatıon Of The Effect Of The Use Of Vırtual Realıty Technology On Sleep Qualıty And Mental Well-Beıng In Multıple Sclerosıs Patıents
- ClinicalTrials.gov ID
- NCT06074419
- Acronym / sponsor ID
- haticeyagci
- Conditions
- Nursing Caries
- Keywords
- VİRTUAL REALİTY, SLEEP QUALITY, MENTAL WELL-BEING, MULTIPLE SCLEROSIS, NURSING
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 10 Oct 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 is known that being in natural environments helps increase a person's well-being. It may not always be easy for individuals with neurological diseases to reach these environments due to their mobility limitations, other symptoms and other diseases. Virtual reality technology offers us unlimited opportunities to create these environments digitally and safely.
In this research, virtual nature videos will be watched using virtual reality glasses. This process will be done in the experimental group. In the control group, no action will be taken. The scores of the two groups will be compared.
The purpose of this presentation is to investigate whether virtual reality affects the mental well-being of beginners and the limits of sleep.
Detailed description
Multiple Sclerosis (MS) is an autoimmune, neurodegenerative disease characterized by demyelination and sclerotic plaques in the brain and spinal cord. Physical and psychological symptoms occur depending on the affected area. Environmental, viral, genetic and autoimmune factors are thought to play a role in the formation of MS disease, the etiology of which is still unknown. It ranks first among non-traumatic central nervous system diseases that cause disability in young adults. The disease is more common in women.
The disease is clinically seen in four types. These; relapsing-remitting (RRMS), primary progressive (PPMS), secondary progressive (SPMS) and relapsing progressive (RPMS) types.
A wide variety of symptoms occur in MS patients due to demyelination and inflammation. It causes loss of abilities such as motor disorders, cerebellar disorders, bladder-intestinal disorders, sensory disorders, cognitive disorders, emotional disorders and balance-coordination disorders. Apart from these, it has been shown that many social and psychological problems accompany these symptoms.
Mental disorders are more common in MS than in other neurological diseases. The resulting physical and mental disorders negatively affect the mental well-being of patients.
The risk of sleep problems is also increased in MS patients. It has been shown in the literature that MS patients have increased sleep problems compared to the general population and individuals with other chronic diseases. It has been reported that the incidence of sleep problems is between 25-54%. Controlling sleep problems of MS patients will improve their quality of life.
Virtual reality is alternative worlds in which a person can move as if he were living in any environment. In these virtual worlds, control is completely in the hands of the practitioners. For this reason, it allows the design of individual-specific environments and the application over and over again. Apart from that, it is a safe and interesting method. It is a method that can be applied with tools such as glasses, computers, headphones and sensors. Today, it is preferred in the treatment and rehabilitation of many neurological and chronic diseases.
There are different methods used to improve mental state and sleep quality in MS patients. This study will investigate whether the use of virtual reality glasses affects the mental well-being and sleep quality of patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The experimental group will be shown a nature video through virtual reality glasses. No action will be applied to the control group. The two groups will be compared in terms of sleep quality and mental well-being
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Occulus quest 2 virtual reality glassesVirtual reality glasses will be applied 2 days a week for 6 weeks. A sleep quality scale and a mental well-being scale will be applied before and after the procedure. |
| Control group | No intervention | –There will be no virtual reality application. Sleep quality and mental well-being scale will be applied every 6 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being diagnosed with multiple sclerosis (any type)
- Not being in an MS attack period
- Being between the ages of 18-80
- Having the level of awareness to maintain healthy communication
- Volunteering to participate in the study
Key exclusion criteria (9 listed)
- Having impaired cognitive functions at a level that prevents maintaining healthy communication and responding to data collection forms.
- Being in an MS attack phase
- Being diagnosed with sleep apnea or any sleep disorder
- Using sleeping pills
- Having a major psychiatric disorder
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 |
|---|---|---|
| Occulus quest 2 virtual reality glassesPatients will be shown nature videos via the specified virtual reality connection. | Device | Experimental group |
Primary outcome
Pittsburgh sleep quality index score
Time frame: 6 week
The scale evaluates sleep quality over the past 1 month. The first 19 questions are answered by the patient himself, and the last 5 questions are answered by the patient's relative or bed partner, making a total of 24 questions. The first 18 questions answered by the patient himself (self-assessment) are included in the scoring. The remaining 6 questions are used only for clinical information. A score higher than five indicates that sleep quality is significantly inadequate. The scores obtained after 6 weeks of proces will be analyzed. If sufficient power is not achieved as a result of the analysis, the number of samples will be increased.
Warwick-Edinburgh Mental Well-Being Scale score
Time frame: 6 week
The scale covers subjective and psychological well-being states. The scale consists of 14 questions of five-point Likert type. There are no sub-dimensions in the scale. Participants answer the questions as 1: I completely disagree, 2: I disagree, 3: I somewhat agree, 4: I agree and 5: I completely agree. The lowest score from the scale is 14 and the highest score is 70. There are no reverse items in the scale. As the score obtained from the scale increases, the level of mental well-being also increases.The scores obtained after 6 weeks of proces will be analyzed. If sufficient power is not achieved as a result of the analysis, the number of samples will be increased.
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 10 Sep 2026.
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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.
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 Occulus quest 2 virtual reality glasses in people with Nursing Caries, run by Ataturk 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 9 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 10 Sep 2026. 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?
Pittsburgh sleep quality index score (time frame: 6 week). 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 10 Sep 2026.