Smart Pain Assesment Tool Based on Internet of Things

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Smart pain assessment tool

• Registration Number: NCT03061240
• Lead Sponsor: University of Turku

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 Timeline

• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Study Start: 2017-11-20
• Primary Completion: 2018-06-11
• Study Completion: 2018-06-11
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Postoperative patients	Smart pain assessment tool	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.

Primary Outcome Measures

Name	Time	Method
Facial muscle activity	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 Outcome Measures

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

Trial Locations

Locations (1)

University of Turku; 🇫🇮 Turku, Finland