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Completed

NCT Number: NCT05085821

Cardio-visual Stimulation in Augmented Reality for Pain Reduction

The objective of this study is to evaluate the feasibility and efficacy of an Augmented Reality (AR) biofeedback intervention to alleviate pain symptoms in individuals suffering from chronic pain of the hand and/or the forearm.

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Key information

Conditions

Regional Pain Syndrome Chronic Pain Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

About this study

Chronic pain is a major public health problem with implications for high health care costs, lost productivity and an estimated financial burden of $500 billion. Individuals with chronic pain are also at an increased risk of developing an opioid use disorder.

Chronic pain has previously been associated with a distorted body representation, in particular of the affected body parts. Virtual Reality (VR) studies using embodiment-, respiration-, and heart-beat related feedback have demonstrated positive effects for induced pain in healthy participants (e.g., increased pain thresholds) and chronic pain in patient populations (e.g., decreased subjective pain, improved functionality, improved physiological markers of pain). Based on these studies, the AR intervention evaluated here aims to alleviate subjective pain symptoms and improve physiological pain markers in chronic pain patients using heartbeat-related feedback.

This within-subject study will compare subjective pain ratings before, during, and after an AR intervention that provides visual feedback of participants' on-going heartbeat in relation to their affected limb. Primary outcomes include subjective reports from participants (perceived efficacy, acceptability, and demand) and the intervention's clinical feasibility, including reports from therapists. Secondary outcomes include changes in heart rate and variability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be over 18 years of age
  • Present permanent chronic pain (for more than 3 months), secondary to a peripheral pathology (traumatic, orthopedic or neurological), located in the hand or forearm.

Exclusion criteria

  • Pregnant women
  • People in emergency situations
  • Persons unable to give informed consent
  • Persons who are mentally or linguistically unable to understand the research test instructions
  • Individuals who are not available to complete the entire study protocol
  • Cognitive impairments that prevent the use of the equipment
  • Psychiatric disorders
  • Patients with seizure disorders
  • Patients with central hemineglect
  • Pain secondary to central nervous system pathology
  • Patients with arrhythmia
  • Patients with head tremors or head shaking.

Treatment and study plan

HEART

Device

In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)

PLACEBO

Device

In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)

Primary outcomes

  1. Change in perceived pain

    Time frame: change in pain rating will be evaluated when participants first wear the Head-Mounted Display (baseline), after 3 minutes of video-passthrough (Pre), after 3 minutes of cardio-visual stimulation (post), after 3 minutes of video-passthrough (final)

    The patient moves a cursor on a Visual Analog Scale to indicate their currently perceived level of pain. The gauge ranges from "no pain" (0) to "worst pain imaginable" (10).

  2. Change in Heart-Rate Variability (time domain)

    Time frame: a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)

    time-domain metrics of heart-rate variability [ms]

  3. Change in Heart-Rate Variability (frequency domain)

    Time frame: a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)

    frequency-domain metric of heart-rate variability (power)

Secondary outcomes

  1. Questionnaire

    Time frame: The first day of the study

    Questionnaire on the sensations, usability, and satisfaction with the augmented reality stimulation using a Visual Analog Scale (0-10) where higher scores indicate agreement with the questionnaire item.

  2. Questionnaire

    Time frame: The second day of the study

    Questionnaire on the sensations, usability, and satisfaction with the augmented reality stimulation using a Visual Analog Scale (0-10) where higher scores indicate agreement with the questionnaire item.

  3. Questionnaire

    Time frame: The third day of the study

    Questionnaire on the sensations, usability, and satisfaction with the augmented reality stimulation using a Visual Analog Scale (0-10) where higher scores indicate agreement with the questionnaire item.

  4. Questionnaire

    Time frame: The fourth day of the study

    Questionnaire on the sensations, usability, and satisfaction with the augmented reality stimulation using a Visual Analog Scale (0-10) where higher scores indicate agreement with the questionnaire item.

Sponsors and collaborators

Lead sponsor

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Other

Collaborators

  • Mindmaze SA

Registry information

Acronym: HEART

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2021
Registry last updated
Feb 6, 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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