Chronic PainNCT06154850
Effects of Virtual Reality on Brain Hemodynamic Activity in Chronic Pain
A study testing Immersive virtual reality and Non-immersive virtual reality in people with Chronic Pain and Rheumatoid Arthritis, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Virtual reality systems have been applied in recent years to reduce pain intensity and fear of movement in individuals with acute and chronic pain. The main mechanism of virtual reality methods in pain control is to provide the effect of distraction from pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Pain, Rheumatoid Arthritis, Virtual Reality
- What is being tested?
- Immersive virtual reality and Non-immersive virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2023to 19 Mar 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with rheumatoid arthritis,
- Right hand dominant,
Who cannot join
- A history of acute pain up to 3 days prior to the date of evaluation,
- Any psychiatric and neurological diagnosis,
- Have a cognitive problem that prevents them from adapting to the working procedure,
- Using centrally acting medications and anti-depressants.
- Presence of neuropathic pain,
- Presence of vision or hearing problems,
- Any psychiatric and neurological diagnosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Mehmet Ali Aydınlar University
Istanbul
About this study
Virtual reality systems have been applied in recent years to reduce pain intensity and fear of movement in individuals with acute and chronic pain. The main mechanism of virtual reality methods in pain control is to provide the effect of distraction from pain. Virtual reality systems allow the individuals to feel themselves in a different environment and shift their attention to the game they are playing or the virtual world created rather than the pain they feel. This is thought to be the main mechanism of pain control. However, the cortical mechanism of the reduction in pain caused by virtual reality methods, especially in individuals with chronic pain, has not been fully elucidated.
It is predicted that the integration of virtual reality methods into treatment protocols will gradually increase by time, especially as a result of the reflection of technological developments in clinical practice. At this point, fNIRS, which enables the assessment of the functionality of brain areas during movement, has the potential to reveal the response of the effect provided by virtual reality technology in the prefrontal cortex.
The aims of our study were to examine brain hemodynamic activity during the experience of non-immersive and immersive virtual reality environments and the change in pain intensity after virtual reality applications in individuals with rheumatic diseases with chronic pain.
- Conditions
- Chronic Pain, Rheumatoid Arthritis, Virtual Reality
- Being tested
- Immersive virtual reality, Non-immersive virtual reality
- Medical subject headings
- Chronic Pain, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual realityOther
Oculus Quest 2 will be used with NatureTrek application for 10 minutes.
Non-immersive virtual realityOther
Patients will watch a video including scenes from NatureTrek application on a screen.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality | Experimental | Individuals will wear the headset for 10 minutes while playing NatureTrek application Receives: Other: Immersive virtual reality |
| Non-immersive Virtual Reality | Active comparator | Individuals will watch a video including scenes from NatureTrek application for 10 minutes. Receives: Other: Non-immersive virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional near infrared spectrosopy
Real-time measurement and monitoring of brain hemodynamics will be performed with a 24-channel fNIRS device (Brite 24, Artinis, The Netherlands). Recordings will be obtained with sensors placed in the prefrontal cortex. In the study design, after the sensors are placed on the scalp, a 1-minute recording will first be taken in the resting position. Afterwards, painful and painless mechanical stimuli will be given to the subjects during the viewing of fully immersive and non-immersive virtual reality environments.
Measured: During the intervention
Numeric Pain Rating Scale
Numeric Pain Rating Scale will be used to quantify pain severity after both virtual reality applications. Patients will be asked to report their pain numerically as 0: no pain; 10: unbearable pain.
Measured: Immediately after the intervention
Secondary outcomes (2)
Perceived Level of Fun
The level of entertainment perceived by the participants after each virtual reality application will be evaluated on a scale of 0 to 10 (0 = not entertained at all, 10 = very entertained).
Measured: Immediately after the intervention
Heart rate variability
Heart rate variability will be assessed using a wearable belt (Polar OH1 heart rate monitor).
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start7 Nov 2023
- Primary completion10 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154850
- Sponsor's protocol ID
- ATADEK 2022-14/06
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 27 Mar 2024
- Results posted
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality on Brain Hemodynamic Activity in Chronic Pain
- ClinicalTrials.gov ID
- NCT06154850
- Acronym / sponsor ID
- ATADEK 2022-14/06
- Conditions
- Chronic Pain, Rheumatoid Arthritis, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 4 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.
Virtual reality systems have been applied in recent years to reduce pain intensity and fear of movement in individuals with acute and chronic pain. The main mechanism of virtual reality methods in pain control is to provide the effect of distraction from pain. Virtual reality systems allow the individuals to feel themselves in a different environment and shift their attention to the game they are playing or the virtual world created rather than the pain they feel. This is thought to be the main mechanism of pain control. However, the cortical mechanism of the reduction in pain caused by virtual reality methods, especially in individuals with chronic pain, has not been fully elucidated.
It is predicted that the integration of virtual reality methods into treatment protocols will gradually increase by time, especially as a result of the reflection of technological developments in clinical practice. At this point, fNIRS, which enables the assessment of the functionality of brain areas during movement, has the potential to reveal the response of the effect provided by virtual reality technology in the prefrontal cortex.
The aims of our study were to examine brain hemodynamic activity during the experience of non-immersive and immersive virtual reality environments and the change in pain intensity after virtual reality applications in individuals with rheumatic diseases with chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality | Experimental | Other: Immersive virtual realityIndividuals will wear the headset for 10 minutes while playing NatureTrek application |
| Non-immersive Virtual Reality | Active comparator | Other: Non-immersive virtual realityIndividuals will watch a video including scenes from NatureTrek application for 10 minutes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with rheumatoid arthritis,
- Right hand dominant,
Key exclusion criteria (7 listed)
- A history of acute pain up to 3 days prior to the date of evaluation,
- Any psychiatric and neurological diagnosis,
- Have a cognitive problem that prevents them from adapting to the working procedure,
- Using centrally acting medications and anti-depressants.
- Presence of neuropathic pain,
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 |
|---|---|---|
| Immersive virtual realityOculus Quest 2 will be used with NatureTrek application for 10 minutes. | Other | Immersive Virtual Reality |
| Non-immersive virtual realityPatients will watch a video including scenes from NatureTrek application on a screen. | Other | Non-immersive Virtual Reality |
Primary outcome
Functional near infrared spectrosopy
Time frame: During the intervention
Real-time measurement and monitoring of brain hemodynamics will be performed with a 24-channel fNIRS device (Brite 24, Artinis, The Netherlands). Recordings will be obtained with sensors placed in the prefrontal cortex. In the study design, after the sensors are placed on the scalp, a 1-minute recording will first be taken in the resting position. Afterwards, painful and painless mechanical stimuli will be given to the subjects during the viewing of fully immersive and non-immersive virtual reality environments.
Numeric Pain Rating Scale
Time frame: Immediately after the intervention
Numeric Pain Rating Scale will be used to quantify pain severity after both virtual reality applications. Patients will be asked to report their pain numerically as 0: no pain; 10: unbearable pain.
2 secondary outcomes
Perceived Level of Fun
Time frame: Immediately after the intervention
Heart rate variability
Time frame: During the intervention
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 Mar 2024.
- 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.
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 Immersive virtual reality and Non-immersive virtual reality in people with Chronic Pain and Rheumatoid Arthritis, run by Acibadem 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 2 inclusion and 7 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 Mar 2024. 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?
Functional near infrared spectrosopy (time frame: During the intervention). 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 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.