PainNCT04268589
Virtual Reality Effect in Geriatric Individuals
A study testing virtual reality game in people with Pain and Depression, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of a virtual reality experience on pain, depression and functional adequacy in geriatric individuals living in a nursing home. A virtual reality video with dance moves has been applied to the experimental group participants. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Depression
- What is being tested?
- virtual reality game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 30 Jun 2019
- 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 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Suffering from musculoskeletal pain in the last 3 years,
- Being energetic (Being independent in the daily life activities),
- Being able to stand up without help before 30 seconds and walk at least six meters without help,
- Individuals with blood sugar ranging between 90-200 mg/dl prior to the application,
- Individuals with blood pressure ranging between 130-70 mm/Hg prior to the application,
- Not having neurological and psychiatric diseases,
Show all 10Show fewer
- No history of fall,
- Being literate,
- Not being visually-hearing impaired,
- Being able to communicate verbally.
Who cannot join
- Pependent patients
- Patients with psychiatric illness
- Patients with joint pain disease diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality Application on Pain, Functional Independence and Depression in Geriatric Individuals
This study aimed to determine the effect of a virtual reality experience on pain, depression and functional adequacy in geriatric individuals living in a nursing home.
A virtual reality video with dance moves has been applied to the experimental group participants. Each video takes 3 minutes, and the elderly person has been put into practice at least 30 minutes after having breakfast in 3-minute periods and at least 30 minutes after dinner. In the morning and evening, 15 minutes, 2 times a day, a total of 9 days were applied for 3 weeks. The application lasted a total of 3 weeks. Scales were applied 1 week after the virtual reality application was completed and 1 month after the experimental group. The scales were filled in the control group at the same time.
Read the detailed description
It is recommended that the future studies be conducted with larger samples on pain, depression, life quality and functionality.
- Conditions
- Pain, Depression
- Being tested
- virtual reality game
- Keywords
- geriatric pain, geriatric depression
- Medical subject headings
- Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality gameOther
Also called routine
routine
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | routine study |
| virtual reality group | Experimental | Three days a week, 2 times a day, 15 minutes in the morning and in the evening for 9 days in total Receives: Other: virtual reality game |
What is being measured
The primary outcome is the main question the study is designed to answer.
The visual analog scale (VAS)
This form includes numbers and is used in the assessment of pain severity. Patients mark their pain severity on a 10 cm ruler which is written no pain on one side and the most severe pain as possible on the other side. It has been stated that VAS is more sensitive and reliable in the measurement of pain severity than one sized scales
Measured: nine days
Geriatric Depression Scale
The scale was developed by Yesavage with the aim of assessing the depression symptoms of old persons and consists of 15 questions in total. In the assessment, 1 point is given to each "no" answer in the positive questions and to each "yes" answer in the negative questions. A score of 6 and higher in the scale is accepted as meaningful for the diagnosis of depression. Reliability and validity tests were performed in our country and Chronbach alpha internal consistency coefficient was found to be 0.92
Measured: nine days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 May 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil İbrahim Tuna, Selcuk University
- Investigators
- Gamze Unver, Principal investigator, Kutahya University of Health SciencesHalil Ibrahim Tuna, Principal investigator, Selcuk UniversityGuler Balci Alparslan, Principal investigator, Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268589
- Sponsor's protocol ID
- OGUU
- Status last verified
- Feb 2020
- First submitted
- 21 Jan 2020
- Last updated
- 17 Feb 2020
- 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 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Application on Pain, Functional Independence and Depression in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT04268589
- Acronym / sponsor ID
- OGUU
- Conditions
- Pain, Depression
- Keywords
- geriatric pain, geriatric depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 Feb 2020 (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 aimed to determine the effect of a virtual reality experience on pain, depression and functional adequacy in geriatric individuals living in a nursing home.
A virtual reality video with dance moves has been applied to the experimental group participants. Each video takes 3 minutes, and the elderly person has been put into practice at least 30 minutes after having breakfast in 3-minute periods and at least 30 minutes after dinner. In the morning and evening, 15 minutes, 2 times a day, a total of 9 days were applied for 3 weeks. The application lasted a total of 3 weeks. Scales were applied 1 week after the virtual reality application was completed and 1 month after the experimental group. The scales were filled in the control group at the same time.
Detailed description
It is recommended that the future studies be conducted with larger samples on pain, depression, life quality and functionality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –routine study |
| virtual reality group | Experimental | Other: virtual reality gameThree days a week, 2 times a day, 15 minutes in the morning and in the evening for 9 days in total |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Suffering from musculoskeletal pain in the last 3 years,
- Being energetic (Being independent in the daily life activities),
- Being able to stand up without help before 30 seconds and walk at least six meters without help,
- Individuals with blood sugar ranging between 90-200 mg/dl prior to the application,
- Individuals with blood pressure ranging between 130-70 mm/Hg prior to the application,
Key exclusion criteria (3 listed)
- Pependent patients
- Patients with psychiatric illness
- Patients with joint pain disease diagnosis
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 gameAlso: routineroutine | Other | virtual reality group |
Primary outcome
The visual analog scale (VAS)
Time frame: nine days
This form includes numbers and is used in the assessment of pain severity. Patients mark their pain severity on a 10 cm ruler which is written no pain on one side and the most severe pain as possible on the other side. It has been stated that VAS is more sensitive and reliable in the measurement of pain severity than one sized scales
Geriatric Depression Scale
Time frame: nine days
The scale was developed by Yesavage with the aim of assessing the depression symptoms of old persons and consists of 15 questions in total. In the assessment, 1 point is given to each "no" answer in the positive questions and to each "yes" answer in the negative questions. A score of 6 and higher in the scale is accepted as meaningful for the diagnosis of depression. Reliability and validity tests were performed in our country and Chronbach alpha internal consistency coefficient was found to be 0.92
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 Feb 2020.
- 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.
Gamze Unver principal investigator
Kutahya University of Health Sciences
Halil Ibrahim Tuna principal investigator
Selcuk University
Guler Balci Alparslan principal investigator
Osmangazi 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 game in people with Pain and Depression, run by Selcuk 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 10 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 Feb 2020. 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?
The visual analog scale (VAS) (time frame: nine days). 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 Feb 2020.