Cardio-visual Stimulation in Augmented Reality for Pain Reduction
HEART
1 other identifier
interventional
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2021
CompletedFirst Submitted
Initial submission to the registry
May 3, 2021
CompletedFirst Posted
Study publicly available on registry
October 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2023
CompletedFebruary 6, 2024
December 1, 2022
2.2 years
May 3, 2021
February 5, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Change in perceived pain
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).
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)
Change in Heart-Rate Variability (time domain)
time-domain metrics of heart-rate variability \[ms\]
a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)
Change in Heart-Rate Variability (frequency domain)
frequency-domain metric of heart-rate variability (power)
a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)
Secondary Outcomes (4)
Questionnaire
The first day of the study
Questionnaire
The second day of the study
Questionnaire
The third day of the study
Questionnaire
The fourth day of the study
Study Arms (4)
Experimental 1: HEART - Placebo - HEART - Placebo
EXPERIMENTALThe patient receives visual feedback in an augmented reality environment in four session, over two weeks. Week 1: HEART, Placebo (after \>24hour washout) Week 2: HEART, Placebo (after \>24hour washout)
Experimental 2: HEART - Placebo - Placebo - HEART
EXPERIMENTALThe patient receives visual feedback in an augmented reality environment in four session, over two weeks. Week 1: HEART, Placebo (after \>24hour washout) Week 2: Placebo, HEART (after \>24hour washout)
Experimental 3: Placebo - HEART - Placebo - HEART
EXPERIMENTALThe patient receives visual feedback in an augmented reality environment in four session, over two weeks. Week 1: Placebo, HEART (after \>24hour washout) Week 2: Placebo, HEART (after \>24hour washout)
Experimental 4: Placebo - HEART - HEART - Placebo
EXPERIMENTALThe patient receives visual feedback in an augmented reality environment in four session, over two weeks. Week 1: HEART, Placebo (after \>24hour washout) Week 2: Placebo, HEART (after \>24hour washout)
Interventions
In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54000, France
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Paysant, Pr
UGECAM Nord Est
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 3, 2021
First Posted
October 20, 2021
Study Start
April 20, 2021
Primary Completion
June 29, 2023
Study Completion
June 29, 2023
Last Updated
February 6, 2024
Record last verified: 2022-12