Smart Pain Assesment Tool Based on Internet of Things
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Turku
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Facial muscle activity
Study Overview
Brief Summary
This study is the second phase of a research project called "Smart Pain Assessment Tool based on Internet-of-Things". During the course of this project, a smart pain assessment tool (SPA) to detect and assess pain employing behavioural and physiologic indicators will be developed. We aim to assess pain based on changes in electromyographic (EMG) activity in facial muscles, i.e. changes in facial expressions and simultaneously use physiologic signs such as heart rate, respiratory rate and galvanic skin response as adjuvant measures to develop an algorithm for pain assessment in critically ill patients.
Detailed Description
The aim of this "smart pain assessment tool based on internet of things" SPA-research project is to develop an automatic and versatile pain assessment tool algorithm for detection and assessment of pain in a reliable and objective way in non-communicative patients. The final objective of the research project is to develop a smart pain assessment tool to detect and assess pain employing behavioural and physiologic indicators for a wide range of users/patients from infants to elderly people who are unable to communicate normally. The research project consists of three clinical phases (European Commision. Meddev 2.7/4/2010). The clinical phase I of the research project focused on developing pain assessment techniques involuntary working-age healthy study subjects. This current Clinical phase II includes the further development and research of the smart pain assessment tool in elective (non emergency) postoperative surgical patients during their stay after surgery in a recovery room.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is scheduled for major surgery that requires general anesthesia and is likely to cause moderate to severe pain postoperatively which needs to be treated with systemic analgesics
- •Ability to communicate
- •Written informed consent
- •Healthy facial skin
Exclusion Criteria
- •Subject treated with local anesthesia during surgery
- •Any diagnosed condition affecting cognitive functions
- •Surgery affecting hands where pulse oximetry and galvanic skin reaction are recorded or areas where facial muscle activity is measured
- •Any diagnosed condition affecting central nervous system, facial nerves or muscles.
- •Significant facial hair growth in the area where the sensors will be attached
- •Tattoos in the area where the sensors will be attached
Outcomes
Primary Outcomes
Facial muscle activity
Time Frame: 2 hours after surgery when the subject has woken up
The device is designed for multi-channel EMG acquisition from facial skin. Measuring a combination of EMG signals and their energy level (amplitude).
Secondary Outcomes
- Skin conductance(2 hours after surgery when the subject has woken up)
- Respiratory rate(2 hours after surgery when the subject has woken up)
- Pain assesment by VAS(2 hours after surgery when the subject has woken up)
- Heart rate(2 hours after surgery when the subject has woken up)
- Oxygen saturation(2 hours after surgery when the subject has woken up)
Investigators
Sanna Salanterä
Professor
University of Turku