Smart Pain Assesment Tool Based on Internet of Things

NCT03061240 | Completed

• 1 other identifier: 29092016
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Internet of Things

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Skin conductance

  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

• Respiratory rate

  2 hours after surgery when the subject has woken up

• Oxygen saturation

  2 hours after surgery when the subject has woken up

Study Arms (1)

Postoperative patients

EXPERIMENTAL

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

Interventions

Smart pain assessment tool DEVICE

We record and analyze multiple bio-signals from post-operative patients in the attempt to evaluate their experienced pain.

Postoperative patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turku: lead
• Academy of Finland: collaborator
• Turku University Hospital: collaborator

Study Sites (1)

University of Turku

Turku, 20140, Finland

Location

Related Publications (5)

• 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.

  PMID: 22404146 BACKGROUND

• 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.

  PMID: 14995936 BACKGROUND

• 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.

  PMID: 19262917 BACKGROUND

• 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.

  PMID: 19183409 BACKGROUND

• EPoSS. 2008. Internet of Things in 2020: a Roadmap for the Future. European Technology Platform on Smart Systems Integration. European Commission Information Society.

  BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanna Salanterä, Prof

  University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 23, 2017
• Study Start: November 20, 2017
• Primary Completion: June 11, 2018
• Study Completion: June 11, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

FI (1)