No intervention: Observational study with no intervention - Monitoring
Study summary
The pAIn-sense study aims to revolutionize the monitoring and treatment of chronic pain, a major health concern that significantly impacts psychological well-being and quality of life. Traditional approaches to pain management face challenges like unspecific drug use and high healthcare costs, and they often leave patients dissatisfied. PAIn-sense aims at comprehensively understanding pain from both physical and emotional perspectives. To accomplish this, the study will employ advanced Artificial Intelligence (AI) techniques and wearable sensing technology. The study aims to monitor patients continuously, during both day and night activities, to gather a multidimensional set of data on their physiological, psychosocial, and pain conditions.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Ongoing nociceptive pain after an injury or Neuropathic pain (acute or chronic)
* Familiar with using electronic devices
Exclusion Criteria:
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Unable or not willing to give informed consent
Primary outcome measure(s)
Pain level — Up to one month Reported trough a digital health platform by the patients. The level and its dynamic are monitored daily. The pain level is recorded through a score from 1 to 10 that is reported trough a digital health platform by the patients.
Psychosocial components of pain experience through questionnaires — Up to one month Monitored using the wearable technology and software digital platforms. Questionnaires will be presented to the patients and will include anxiety, depression, fatigue, pain catastrophizing, sleep, awareness, pain efficacy, treatment expectation
Physiological components of pain and pain attacks in the physiological signals — Up to one month Measured and extracted from wearable technology worn continuously. Physiological biomarkers will include Skin Conductance (SC), blood volume pulse (BVP), Heart rate (HR), Brain signals (functional magnetic resonance imaging, electroencephalogram), movements (accelerometer, IMU), temperature.
Psychological and clinical factors affecting pain — Up to one month Identified using questionnaires. Scales are usually represented with values from 0 to 10 with 0 best outcome and 10 worst outcome.
Medication intake (rate and times per day) — Up to one month As described in each patient's constant pain therapy or reported by the patient on request using the platform. Medication will be measure in terms of rate of medications and changes during the protocols, times per day of intake, number of times a on-request medication is taken.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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