Effects of Virtual Reality on Brain Hemodynamic Activity in Chronic Pain

NCT06154850 | Completed

• 1 other identifier: ATADEK 2022-14/06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Rheumatoid Arthritis; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Perceived Level of Fun

  Immediately after the intervention

• Heart rate variability

  During the intervention

Other Outcomes (4)

• Pain Catastrophizing Scale

  Pre-intervention

• Tampa Kinesiophobia Scale

  Pre-intervention

• Adverse effects

  Immediately after the intervention

Study Arms (2)

Immersive Virtual Reality

EXPERIMENTAL

Individuals will wear the headset for 10 minutes while playing NatureTrek application

Other: Immersive virtual reality

Non-immersive Virtual Reality

ACTIVE COMPARATOR

Individuals will watch a video including scenes from NatureTrek application for 10 minutes.

Other: Non-immersive virtual reality

Interventions

Immersive virtual reality OTHER

Oculus Quest 2 will be used with NatureTrek application for 10 minutes.

Immersive Virtual Reality

Non-immersive virtual reality OTHER

Patients will watch a video including scenes from NatureTrek application on a screen.

Non-immersive Virtual Reality

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with rheumatoid arthritis,
• Right hand dominant,

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead
• Kartal Dr. Lütfi Kirdar City Hospital: collaborator

Study Sites (1)

Acıbadem Mehmet Ali Aydınlar University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 4, 2023
• Study Start: November 7, 2023
• Primary Completion: March 10, 2024
• Study Completion: March 19, 2024
• Last Updated: March 27, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)