NCT05085821

Cardio-visual Stimulation in Augmented Reality for Pain Reduction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Regional Pain Syndrome
• Chronic Pain Syndrome

Interventions

Type	Name	Description
DEVICE	HEART	In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
DEVICE	Placebo	In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)

Timeline

• Start date: 2021-04-20
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2021-10-20
• Last updated: 2024-02-06

Locations

1 site across 1 country: France