Effects of Virtual Reality on Brain Hemodynamic Activity in Chronic Pain

Rheumatoid Arthritis Clinical Trial

Official title:

Effects of Virtual Reality on Brain Hemodynamic Activity in Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06154850
• Other study ID #: ATADEK 2022-14/06
• Status: Completed
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: March 19, 2024

Study information

• Verified date: November 2023
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 19, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Diagnosed with rheumatoid arthritis,
• Right hand dominant,

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Rheumatoid Arthritis
• Virtual Reality

Intervention

Other:
• Immersive virtual reality
Oculus Quest 2 will be used with NatureTrek application for 10 minutes.
• Non-immersive virtual reality
Patients will watch a video including scenes from NatureTrek application on a screen.

Locations

Country	Name	City	State
Turkey	Acibadem Mehmet Ali Aydinlar University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Acibadem University	Kartal Dr. Lütfi Kirdar City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Pre-intervention
Other	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.	Pre-intervention
Other	Adverse effects	VR related events included dizziness, nausea, eye strain, and seizure.	Immediately after the intervention
Other	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.	Pre-intervention
Primary	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.	During the intervention
Primary	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.	Immediately after the intervention
Secondary	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).	Immediately after the intervention
Secondary	Heart rate variability	Heart rate variability will be assessed using a wearable belt (Polar OH1 heart rate monitor).	During the intervention