An interventional study of Immersive virtual reality and Non-immersive virtual reality in Chronic Pain, Rheumatoid Arthritis and Virtual Reality, sponsored by Acibadem University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by Acibadem University · Not applicable, Interventional, and Treatment
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.
2,930 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 2,160 interventional studies indexed under Chronic Pain.
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Exclusion criteria:
Individuals will wear the headset for 10 minutes while playing NatureTrek application
Other: Immersive virtual reality
Individuals will watch a video including scenes from NatureTrek application for 10 minutes.
Other: Non-immersive virtual reality
Oculus Quest 2 will be used with NatureTrek application for 10 minutes.
Patients will watch a video including scenes from NatureTrek application on a screen.
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.
Time frame: 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.
Time frame: Immediately after the intervention
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).
Time frame: Immediately after the intervention
Heart rate variability
Heart rate variability will be assessed using a wearable belt (Polar OH1 heart rate monitor).
Time frame: During the intervention
Pain Catastrophizing Scale
Pain Catastrophizing Scale assesses catastrophic feelings associated with pain, is a Likert-type self-assessment scale consisting of 13 items rated between 0 and 4 points. The total score ranges from 0 to 52 and includes rumination, magnification and helplessness subscales. Higher scores on the scale indicate higher levels of pain catastrophizing.
Time frame: Pre-intervention
Tampa Kinesiophobia Scale
Tampa Kinesiophobia Scale consists of 17 questions and is used to assess fear and avoidance behaviors in diseases related to musculoskeletal injuries. The scale uses a 4-point Likert scoring system (1=strongly disagree and 4=strongly agree). The total score is calculated after reversing questions 4, 8, 12 and 16 and ranges from 17 to 68. Higher scores indicate higher levels of kinesiophobia.
Time frame: Pre-intervention
Adverse effects
VR related events included dizziness, nausea, eye strain, and seizure.
Time frame: Immediately after the intervention
Pain Detect Questionnaire
PainDETECT is a validated self-report tool to identify neuropathic pain features in a range of conditions. Pain Detect Questionnaire consists of 17 questions, and the maximum score is 30. Scores equal or above 19 indicate the presense of likely neuropathic pain.
Time frame: Pre-intervention
Plan to share: No
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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