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Cardio-visual Stimulation in Augmented Reality for Pain Reduction (HEART)

Primary Purpose

Regional Pain Syndrome, Chronic Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HEART
Placebo
Sponsored by
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Regional Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Régional de Médecine Physique et de RéadaptationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Experimental 1: HEART - Placebo - HEART - Placebo

Experimental 2: HEART - Placebo - Placebo - HEART

Experimental 3: Placebo - HEART - Placebo - HEART

Experimental 4: Placebo - HEART - HEART - Placebo

Arm Description

The 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)

The 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)

The 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)

The 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)

Outcomes

Primary Outcome Measures

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 Heart-Rate Variability (time domain)
time-domain metrics of heart-rate variability [ms]
Change in Heart-Rate Variability (frequency domain)
frequency-domain metric of heart-rate variability (power)

Secondary Outcome Measures

Questionnaire
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.
Questionnaire
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.
Questionnaire
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.
Questionnaire
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.

Full Information

First Posted
May 3, 2021
Last Updated
December 5, 2022
Sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Collaborators
Mindmaze SA
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1. Study Identification

Unique Protocol Identification Number
NCT05085821
Brief Title
Cardio-visual Stimulation in Augmented Reality for Pain Reduction
Acronym
HEART
Official Title
Cardio-visual Stimulation in Augmented Reality for Pain Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Collaborators
Mindmaze SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Pain Syndrome, Chronic Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental 1: HEART - Placebo - HEART - Placebo
Arm Type
Experimental
Arm Description
The 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)
Arm Title
Experimental 2: HEART - Placebo - Placebo - HEART
Arm Type
Experimental
Arm Description
The 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)
Arm Title
Experimental 3: Placebo - HEART - Placebo - HEART
Arm Type
Experimental
Arm Description
The 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)
Arm Title
Experimental 4: Placebo - HEART - HEART - Placebo
Arm Type
Experimental
Arm Description
The 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)
Intervention Type
Device
Intervention Name(s)
HEART
Intervention Description
In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Primary Outcome Measure Information:
Title
Change in perceived pain
Description
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).
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)
Title
Change in Heart-Rate Variability (time domain)
Description
time-domain metrics of heart-rate variability [ms]
Time Frame
a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)
Title
Change in Heart-Rate Variability (frequency domain)
Description
frequency-domain metric of heart-rate variability (power)
Time Frame
a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)
Secondary Outcome Measure Information:
Title
Questionnaire
Description
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.
Time Frame
The first day of the study
Title
Questionnaire
Description
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.
Time Frame
The second day of the study
Title
Questionnaire
Description
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.
Time Frame
The third day of the study
Title
Questionnaire
Description
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.
Time Frame
The fourth day of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Pierret, PhD
Phone
03 83 52 67 61
Email
jonathan.pierret@ugecam.assurance-maladie.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Paysant, Pr
Organizational Affiliation
UGECAM Nord Est
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Régional de Médecine Physique et de Réadaptation
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie Touillet, Md
Phone
+33 3 82 52 6761
Email
amelie.touillet@ugecam.assurance-maladie.fr
First Name & Middle Initial & Last Name & Degree
Jonathan Pierret, PhD
Phone
+33 3 82 52 6761
Email
jonathan.pierret@ugecam.assurance-maladie.fr

12. IPD Sharing Statement

Learn more about this trial

Cardio-visual Stimulation in Augmented Reality for Pain Reduction

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