Effects of Virtual Reality on Brain Hemodynamic Activity in Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain; Rheumatoid Arthritis; Virtual Reality
• Interventions: Other: Immersive virtual reality; Other: Non-immersive virtual reality

• Registration Number: NCT06154850
• Lead Sponsor: Acibadem University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-07
• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-04
• Primary Completion: 2024-03-10
• Study Completion: 2024-03-19
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immersive Virtual Reality	Immersive virtual reality	Individuals will wear the headset for 10 minutes while playing NatureTrek application
Non-immersive Virtual Reality	Non-immersive virtual reality	Individuals will watch a video including scenes from NatureTrek application for 10 minutes.

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	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.
Functional near infrared spectrosopy	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.

Secondary Outcome Measures

Name	Time	Method
Heart rate variability	During the intervention	Heart rate variability will be assessed using a wearable belt (Polar OH1 heart rate monitor).
Perceived Level of Fun	Immediately after the intervention	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).

Trial Locations

Locations (1)

Acıbadem Mehmet Ali Aydınlar University; 🇹🇷 Istanbul, Turkey