Mental Well-beingNCT05742555
Effect of Virtual Reality on Caregivers of Palliative Care Patients
A study testing Virtual reality intervention in people with Mental Well-being and Quality of Life, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Due to advances in medical technology and accessible health services, the prognosis of diseases has improved and the need for care has increased, and primary caregivers have experienced the increased burden of caring for family members for a long time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Well-being, Quality of Life
- What is being tested?
- Virtual reality intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2023to 20 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Having the ability to read, understand and write Turkish,
- Does not have any psychiatric disorder and does not use drugs for it,
- Having a history of seizures,
- No migraine, vertigo, active nausea, vomiting, headache
Who cannot join
- -Individuals with epilepsyIndividuals with vertigo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Mental Well-Being and Quality of Life of Caregivers of Palliative Care Patients
Due to advances in medical technology and accessible health services, the prognosis of diseases has improved and the need for care has increased, and primary caregivers have experienced the increased burden of caring for family members for a long time.
Because the patient is primarily responsible for continuing patient care in palliative care units and then at home, and especially because they have problems in psychological, social and financial support, caregivers within the family are considered as second-degree patients or occult patients.
Read more
Studies have shown that caregivers have a significant burden of care, therefore they experience serious depression, anxiety and physical problems, isolate themselves from society, and their quality of life decreases significantly.
In recent years, the use of virtual reality, which shows itself in different application areas in the field of health as a safe and useful system, has become widespread. Considering the use of virtual reality in the field of health; It is seen that it is mostly preferred for pain management, physical condition improvement, blood collection, burn treatment, and psychological disorder.
Read the detailed description
Palliative care; It is a multidisciplinary approach that includes interventions to prevent complications and improve the quality of life of people with severe illness. Regardless of the level of development, palliative care units provide service in all countries.
The World Health Organization (WHO) stated that the aim of palliative care is not only to improve the quality of life of patients but also to support caregivers. Care burden is defined as negative subjective and objective consequences such as physical health problems, psychological distress, economic and social problems, deterioration of family relationships and loss of control.
The caregiver feels obliged to provide the patient's treatment, personal care and psychosocial support. The physical, economic and moral burden on the caregiver can negatively affect the caregiver socially, psychologically and physically over time.
Caregivers of palliative care patients have an important responsibility. The relationship between providing care and receiving care is in a delicate balance. caring for the patient; it turns into a dependent, intense, long-term and unilateral obligation. These adversely affect the caregiver's quality of life. In addition to the problems of patient care, caregivers also experience problems such as physical problems, fatigue, sleep disorders, behavioral changes, and loss of social roles. As a result, psychological and emotional disorders may occur in the caregiver. Eliminating the symptoms experienced by the caregiver and improving their quality of life are very important in the caregiving process.
The concept of virtual reality is defined as the combination of reality and imagination by transferring various realities to digital media and using special technological devices thanks to technological tools. The use of virtual reality in the field of health has become widespread and can be used for different purposes. Virtual reality application is most commonly used in patients for pain management, exercise training, burn treatments and psychological disorders. Looking at the literature, watching nature scenes; It has been observed that it reduces blood pressure and heart rate and respiratory rate in people, reduces stress and brain activity, and provides relaxation. No study has been found in the literature on caregivers who underwent virtual reality intervention. In this study, it is aimed to increase the mental well-being and quality of life of the relatives of patients who care for palliative care patients with virtual reality application.
- Conditions
- Mental Well-being, Quality of Life
- Being tested
- Virtual reality intervention
- Keywords
- palliative care, caregiver, mental well-being, quality of life, virtual reality
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality interventionOther
After the relatives of the patients included in the experimental group are informed about the study, they will be asked to fill in the Participant Information Form, Nottingham Health Profile (NSP) and Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ) after obtaining their permission. The virtual reality intervention will be applied to the caregivers at a suitable time of the day (when the patient's care and treatment is not intensive, the caregiver wishes). Different nature scenes (sea, forest, stream) with different types of music (classical music, nature sounds, relaxing music) will be watched for 10 minutes, 3 days a week. The application will be made for 4 weeks. At the end of this period, they will be asked to fill the NSP and WEMİOÖ again as a final test.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Other: Virtual reality intervention |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Mental Well-Being Scale
Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ): WEMİOOS consists of 14 items and deals with the positive mental health of individuals, including psychological well-being and subjective well-being. A minimum of 14 points and a maximum of 70 points are taken from the scale. Higher scores mean higher psychological well-being. The scale is a 5-point Likert scale: "5: I totally agree, 4: I agree, 3: I somewhat agree, , 2: I don't agree, 1: I don't agree at all". All items of the scale are positive.
Measured: through study completion, an average of 7 months
Nottingham Health Profile (NSP)
Nottingham Health Profile (NSP): It measures the health-related quality of life of individuals and the effect of their problems on social role functions. The first part of the scale with 38 items covers quality of life; The second part of 6 items measures the effects of problems on their functions in social roles. The first and second parts of the scale can be used independently of each other. In this study, the first part of the scale, consisting of 38 items and evaluating the quality of life answered as yes-no by the individual, will be used. It consists of 6 sub-dimensions: physical movement, sleep, pain, energy, emotional reactions and social isolation. The score of each sub-dimension ranges from 0-100. The total score is obtained by summing the scores of the 6 sub-dimensions. High scores indicate poor quality of life.
Measured: through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start20 Feb 2023
- Primary completion20 Jun 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Well-beingStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Karaman, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742555
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/451
- Status last verified
- May 2026
- First submitted
- 3 Feb 2023
- Last updated
- 27 May 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Mental Well-Being and Quality of Life of Caregivers of Palliative Care Patients
- ClinicalTrials.gov ID
- NCT05742555
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/451
- Conditions
- Mental Well-being, Quality of Life
- Keywords
- palliative care, caregiver, mental well-being, quality of life, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 24 Feb 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.
Due to advances in medical technology and accessible health services, the prognosis of diseases has improved and the need for care has increased, and primary caregivers have experienced the increased burden of caring for family members for a long time.
Because the patient is primarily responsible for continuing patient care in palliative care units and then at home, and especially because they have problems in psychological, social and financial support, caregivers within the family are considered as second-degree patients or occult patients.
Studies have shown that caregivers have a significant burden of care, therefore they experience serious depression, anxiety and physical problems, isolate themselves from society, and their quality of life decreases significantly.
In recent years, the use of virtual reality, which shows itself in different application areas in the field of health as a safe and useful system, has become widespread. Considering the use of virtual reality in the field of health; It is seen that it is mostly preferred for pain management, physical condition improvement, blood collection, burn treatment, and psychological disorder.
Detailed description
Palliative care; It is a multidisciplinary approach that includes interventions to prevent complications and improve the quality of life of people with severe illness. Regardless of the level of development, palliative care units provide service in all countries.
The World Health Organization (WHO) stated that the aim of palliative care is not only to improve the quality of life of patients but also to support caregivers. Care burden is defined as negative subjective and objective consequences such as physical health problems, psychological distress, economic and social problems, deterioration of family relationships and loss of control.
The caregiver feels obliged to provide the patient's treatment, personal care and psychosocial support. The physical, economic and moral burden on the caregiver can negatively affect the caregiver socially, psychologically and physically over time.
Caregivers of palliative care patients have an important responsibility. The relationship between providing care and receiving care is in a delicate balance. caring for the patient; it turns into a dependent, intense, long-term and unilateral obligation. These adversely affect the caregiver's quality of life. In addition to the problems of patient care, caregivers also experience problems such as physical problems, fatigue, sleep disorders, behavioral changes, and loss of social roles. As a result, psychological and emotional disorders may occur in the caregiver. Eliminating the symptoms experienced by the caregiver and improving their quality of life are very important in the caregiving process.
The concept of virtual reality is defined as the combination of reality and imagination by transferring various realities to digital media and using special technological devices thanks to technological tools. The use of virtual reality in the field of health has become widespread and can be used for different purposes. Virtual reality application is most commonly used in patients for pain management, exercise training, burn treatments and psychological disorders. Looking at the literature, watching nature scenes; It has been observed that it reduces blood pressure and heart rate and respiratory rate in people, reduces stress and brain activity, and provides relaxation. No study has been found in the literature on caregivers who underwent virtual reality intervention. In this study, it is aimed to increase the mental well-being and quality of life of the relatives of patients who care for palliative care patients with virtual reality application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Virtual reality intervention |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years old
- Having the ability to read, understand and write Turkish,
- Does not have any psychiatric disorder and does not use drugs for it,
- Having a history of seizures,
- No migraine, vertigo, active nausea, vomiting, headache
Key exclusion criteria (1 listed)
- -Individuals with epilepsyIndividuals with vertigo
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 interventionAfter the relatives of the patients included in the experimental group are informed about the study, they will be asked to fill in the Participant Information Form, Nottingham Health Profile (NSP) and Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ) after obtaining their permission. The virtual reality intervention will be applied to the caregivers at a suitable time of the day (when the patient's care and treatment is not intensive, the caregiver wishes). Different nature scenes (sea, forest, stream) with different types of music (classical music, nature sounds, relaxing music) will be watched for 10 minutes, 3 days a week. The application will be made for 4 weeks. At the end of this period, they will be asked to fill the NSP and WEMİOÖ again as a final test. | Other | Experimental Group |
Primary outcome
Edinburgh Mental Well-Being Scale
Time frame: through study completion, an average of 7 months
Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ): WEMİOOS consists of 14 items and deals with the positive mental health of individuals, including psychological well-being and subjective well-being. A minimum of 14 points and a maximum of 70 points are taken from the scale. Higher scores mean higher psychological well-being. The scale is a 5-point Likert scale: "5: I totally agree, 4: I agree, 3: I somewhat agree, , 2: I don't agree, 1: I don't agree at all". All items of the scale are positive.
Nottingham Health Profile (NSP)
Time frame: through study completion, an average of 7 months
Nottingham Health Profile (NSP): It measures the health-related quality of life of individuals and the effect of their problems on social role functions. The first part of the scale with 38 items covers quality of life; The second part of 6 items measures the effects of problems on their functions in social roles. The first and second parts of the scale can be used independently of each other. In this study, the first part of the scale, consisting of 38 items and evaluating the quality of life answered as yes-no by the individual, will be used. It consists of 6 sub-dimensions: physical movement, sleep, pain, energy, emotional reactions and social isolation. The score of each sub-dimension ranges from 0-100. The total score is obtained by summing the scores of the 6 sub-dimensions. High scores indicate poor quality of life.
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 27 May 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 Virtual reality intervention in people with Mental Well-being and Quality of Life, 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 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 27 May 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?
Edinburgh Mental Well-Being Scale (time frame: through study completion, an average of 7 months). 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 27 May 2026.