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Completed

NCT Number: NCT06154850

Effects of Virtual Reality on Brain Hemodynamic Activity in Chronic Pain

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acıbadem Mehmet Ali Aydınlar University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immersive Virtual Reality

Other

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

Non-immersive virtual reality

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Perceived Level of Fun

    Time frame: 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).

  2. Heart rate variability

    Time frame: During the intervention

    Heart rate variability will be assessed using a wearable belt (Polar OH1 heart rate monitor).

Other outcomes

  1. Pain Catastrophizing Scale

    Time frame: Pre-intervention

    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.

  2. Tampa Kinesiophobia Scale

    Time frame: Pre-intervention

    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.

  3. Adverse effects

    Time frame: Immediately after the intervention

    VR related events included dizziness, nausea, eye strain, and seizure.

  4. Pain Detect Questionnaire

    Time frame: Pre-intervention

    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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2023
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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