Smart Pain Assesment Tool Based on Internet of Things (SPA)

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Smart pain assessment tool

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20140
    • University of Turku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postoperative patients; 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; We record and analyze multiple bio-signals from post-operative patients in the attempt to evaluate their experienced pain.

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

Collaborators and Investigators

• Sponsor: University of Turku
• Collaborators: Turku University Hospital; Academy of Finland
• Investigators: Principal Investigator: Sanna Salanterä, Prof, University of Turku

Publications and helpful links

General Publications

• Viertio-Oja H, Maja V, Sarkela M, Talja P, Tenkanen N, Tolvanen-Laakso H, Paloheimo M, Vakkuri A, Yli-Hankala A, Merilainen P. Description of the Entropy algorithm as applied in the Datex-Ohmeda S/5 Entropy Module. Acta Anaesthesiol Scand. 2004 Feb;48(2):154-61. doi: 10.1111/j.0001-5172.2004.00322.x. No abstract available.
• Jeitziner MM, Schwendimann R, Hamers JP, Rohrer O, Hantikainen V, Jakob SM. Assessment of pain in sedated and mechanically ventilated patients: an observational study. Acta Anaesthesiol Scand. 2012 May;56(5):645-54. doi: 10.1111/j.1399-6576.2012.02660.x. Epub 2012 Mar 7.
• Prkachin KM. Assessing pain by facial expression: facial expression as nexus. Pain Res Manag. 2009 Jan-Feb;14(1):53-8. doi: 10.1155/2009/542964.
• Ledowski T, Ang B, Schmarbeck T, Rhodes J. Monitoring of sympathetic tone to assess postoperative pain: skin conductance vs surgical stress index. Anaesthesia. 2009 Jul;64(7):727-31. doi: 10.1111/j.1365-2044.2008.05834.x. Epub 2009 Jan 28.
• EPoSS. 2008. Internet of Things in 2020: a Roadmap for the Future. European Technology Platform on Smart Systems Integration. European Commission Information Society.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): June 11, 2018
• Study Completion (Actual): June 11, 2018

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Internet of Things
• Other Study ID Numbers: 29092016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No