Smart Pain Assesment Tool Based on Internet of Things

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.

Official Title
-----------------
Smart Pain Assesment Tool Based on Internet of Things

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Device: Smart pain assessment tool


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postoperative patients<br>We recruit postoperative patients who undergo open surgery and are not receiving local anesthesia. We install a smart pain assessment tool on patient's skin to capture different type of data. | Device: Smart pain assessment tool<br>* We record and analyze multiple bio-signals from post-operative patients in the attempt to evaluate their experienced pain.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial muscle activity | The device is designed for multi-channel EMG acquisition from facial skin. Measuring a combination of EMG signals and their energy level (amplitude). | 2 hours after surgery when the subject has woken up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin conductance | Galvanic skin response (GSR), also known as electrodermal activity (EDA) or skin conductance (SC). | 2 hours after surgery when the subject has woken up | 
| Pain assesment by VAS | Subjective feeling of pain is asked every 10 minutes by using numeric visual analog scale (VAS), values are given from 0-10. | 2 hours after surgery when the subject has woken up | 
| Heart rate | Heart rate is monitored and recorded. | 2 hours after surgery when the subject has woken up | 
| Respiratory rate | Respiratory rate is monitored and recorded. | 2 hours after surgery when the subject has woken up | 
| Oxygen saturation | Oxygen saturation is monitored and recorded. | 2 hours after surgery when the subject has woken up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Internet of Things