Virtual RealityNCT06156540
Virtual Reality Glasses in Palliative Care
A study testing virtual reality glasses in people with Virtual Reality, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Developments in medicine and technology have led to an increase in life expectancy and an increase in the need for palliative care. palliative Care aims to reduce or eliminate a life-threatening situation. The palliative care team cares for the patient and provides informal support to the patient. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 15 Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteering to participate in the research,
- No vision, hearing or perception impairment that prevents communication,
- Not using glasses to wear VR glasses,
- No psychiatric disease,
- Absence of complaints such as migraine, vertigo, active nausea, vomiting, headache,
- Not having someone to help you care for your patient.
Who cannot join
- Wanting to leave the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Glasses on the Psychological Well-Being and Care Burden of Patient Relatives Giving Care to Patients in the Palliative Care Clinic
Developments in medicine and technology have led to an increase in life expectancy and an increase in the need for palliative care. palliative Care aims to reduce or eliminate a life-threatening situation. The palliative care team cares for the patient and provides informal support to the patient. It should provide care that centers on caregivers (patient's relatives). Relatives of patients who provide palliative care are responsible for their care As it increases, problems such as fatigue, hopelessness and anger may occur. Problems experienced by caregivers of patients Eliminating this problem and integrating it into care by providing psychosocial support is essential for the quality of care. caregivers Health technologies can be used to support In our research, we found that virtual reality glasses were used in palliative care clinics. It is aimed to investigate the effect of patient relatives who care for inpatients on the psychological well-being and care burden. A randomized controlled research design was used in the study. The population of the research is a country in Turkey between June and October 2023. The study consisted of patient relatives who provide care to patients in the palliative care clinic of the public hospital in the province. To research Relatives of patients who met the participation criteria and agreed to participate (control group, n=22; experimental group, n=22) constituted the sample. Data were collected from "Caregiver Introduction Form", "Psychological Well-Being Scale", "Caregiving Burden Scale" and "Virtual Reality Glasses". It was collected using the "Satisfaction Form". Before starting the research, a preliminary study was conducted with four patient relatives. of research In the implementation, firstly the preliminary application of the data collection tools was made. Then, the experimental group was given weekly Videos containing 360-degree images were watched using virtual reality glasses for 30 minutes for three days. In the control group No intervention was made. At the end of the research, the final application of the data collection tools was made. From research The data obtained was analyzed with the SPSS 22.0 package program.
- Conditions
- Virtual Reality
- Being tested
- virtual reality glasses
- Keywords
- Virtual reality, Nursing, Palliative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesOther
Using virtual reality glasses, caregivers in the experimental group were shown 360-degree VR relaxing videos.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention was made to the control group. The posttest was administered four weeks after the pretest.As a result, caregivers' care burden and psychological well-being will be measured. |
| Virtual Reality Group | Experimental | A pretest was administered to the experimental group. Then, 360-degree VR videos (nature walks, trips, etc.) were watched three days a week for four weeks. Then, the final test was administered.As a result, caregivers' care burden and psychological well-being will be measured. Receives: Other: virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological well-being
The psychological well-being levels of caregivers will be evaluated using the psychological well-being scale.Psychological well-being scale (PIOS):
It was developed by Diener et al. in 2009 and consists of eight items. The scale measuring socio-psychological well-being is a single-factor and 7-point Likert type (1 = Strongly disagree, 7 = Strongly agree). The lowest score that can be obtained from the scale is 8 and the highest score is 56. A high score from the scale indicates high psychological well-being.
Measured: Four weeks after pretest
Secondary outcomes (1)
Determine maintenance burden
Using the caregiving burden scale, caregivers' caregiving burden will be measured.
Caregiving burden scale:
The scale, developed by Zarit et al. in 1980 and adapted into Turkish by İnci and Erdem (2008), consists of 22 statements that determine the impact of caregiving on the individual's life. Scale items are generally related to the social and emotional domain and are of 4-point Likert type (0 = Never, 4 = Almost always). The lowest score that can be obtained from the scale is 0 and the highest score is 88. A high scale score indicates that the distress experienced is high (0-20 points = no care burden, 21-40 points = light care burden, 41-60 points = moderate care burden, 61-88 points = heavy care burden).
Measured: Four weeks after pretest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start15 Jun 2023
- Primary completion5 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies 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
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, Yadigar Ordu, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156540
- Sponsor's protocol ID
- TUSEB
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be requested from the principal investigator upon reasonable request.
Publications
Ordu Y, Yilmaz S. The effect of using virtual reality goggles on psychological well-being and care burden of informal caregivers of patients hospitalized in a palliative care clinic. Eur J Oncol Nurs. 2024 Dec;73:102711. doi: 10.1016/j.ejon.2024.102711. Epub 2024 Oct 9.
PubMed 39406181
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses on the Psychological Well-Being and Care Burden of Patient Relatives Giving Care to Patients in the Palliative Care Clinic
- ClinicalTrials.gov ID
- NCT06156540
- Acronym / sponsor ID
- TUSEB
- Conditions
- Virtual Reality
- Keywords
- Virtual reality, Nursing, Palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 5 Dec 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.
Developments in medicine and technology have led to an increase in life expectancy and an increase in the need for palliative care. palliative Care aims to reduce or eliminate a life-threatening situation. The palliative care team cares for the patient and provides informal support to the patient. It should provide care that centers on caregivers (patient's relatives). Relatives of patients who provide palliative care are responsible for their care As it increases, problems such as fatigue, hopelessness and anger may occur. Problems experienced by caregivers of patients Eliminating this problem and integrating it into care by providing psychosocial support is essential for the quality of care. caregivers Health technologies can be used to support In our research, we found that virtual reality glasses were used in palliative care clinics. It is aimed to investigate the effect of patient relatives who care for inpatients on the psychological well-being and care burden. A randomized controlled research design was used in the study. The population of the research is a country in Turkey between June and October 2023. The study consisted of patient relatives who provide care to patients in the palliative care clinic of the public hospital in the province. To research Relatives of patients who met the participation criteria and agreed to participate (control group, n=22; experimental group, n=22) constituted the sample. Data were collected from "Caregiver Introduction Form", "Psychological Well-Being Scale", "Caregiving Burden Scale" and "Virtual Reality Glasses". It was collected using the "Satisfaction Form". Before starting the research, a preliminary study was conducted with four patient relatives. of research In the implementation, firstly the preliminary application of the data collection tools was made. Then, the experimental group was given weekly Videos containing 360-degree images were watched using virtual reality glasses for 30 minutes for three days. In the control group No intervention was made. At the end of the research, the final application of the data collection tools was made. From research The data obtained was analyzed with the SPSS 22.0 package program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention was made to the control group. The posttest was administered four weeks after the pretest.As a result, caregivers' care burden and psychological well-being will be measured. |
| Virtual Reality Group | Experimental | Other: virtual reality glassesA pretest was administered to the experimental group. Then, 360-degree VR videos (nature walks, trips, etc.) were watched three days a week for four weeks. Then, the final test was administered.As a result, caregivers' care burden and psychological well-being will be measured. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteering to participate in the research,
- No vision, hearing or perception impairment that prevents communication,
- Not using glasses to wear VR glasses,
- No psychiatric disease,
- Absence of complaints such as migraine, vertigo, active nausea, vomiting, headache,
Key exclusion criteria (1 listed)
- Wanting to leave the research.
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 glassesUsing virtual reality glasses, caregivers in the experimental group were shown 360-degree VR relaxing videos. | Other | Virtual Reality Group |
Primary outcome
psychological well-being
Time frame: Four weeks after pretest
The psychological well-being levels of caregivers will be evaluated using the psychological well-being scale.Psychological well-being scale (PIOS): It was developed by Diener et al. in 2009 and consists of eight items. The scale measuring socio-psychological well-being is a single-factor and 7-point Likert type (1 = Strongly disagree, 7 = Strongly agree). The lowest score that can be obtained from the scale is 8 and the highest score is 56. A high score from the scale indicates high psychological well-being.
1 secondary outcome
Determine maintenance burden
Time frame: Four weeks after pretest
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 26 Dec 2023.
- Derived from this study: PubMed 39406181Ordu Y, Yilmaz S. The effect of using virtual reality goggles on psychological well-being and care burden of informal caregivers of patients hospitalized in a palliative care clinic. Eur J Oncol Nurs. 2024 Dec;73:102711. doi: 10.1016/j.ejon.2024.102711. Epub 2024 Oct 9.
- Individual participant dataSharing planned: No. Data may be requested from the principal investigator upon reasonable request.
Related trials for Virtual Reality
Recruiting
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
Pain, Chronic
Not yet recruiting
Virtual Reality Intervention to Improve Comfort in Hospitalized Hematology Patients
Hematologic Cancer
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Recruiting
Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures
Anxiety
Active, not recruiting
Impact of Force Feedback in VR Training on EEG Biomarkers and Real-World Motor Performance
Motor Skills, Healthy Volunteer
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 glasses in people with Virtual Reality, run by Necmettin Erbakan 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 6 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 26 Dec 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?
psychological well-being (time frame: Four weeks after pretest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06156540, which also lists 1 linked publication.
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 Dec 2023.