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Completed

NCT Number: NCT03061240

Smart Pain Assesment Tool Based on Internet of Things

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Turku

Turku, 20140, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smart pain assessment tool

Device

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

Primary outcomes

  1. 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

  1. Skin conductance

    Time frame: 2 hours after surgery when the subject has woken up

    Galvanic skin response (GSR), also known as electrodermal activity (EDA) or skin conductance (SC).

  2. Pain assesment by VAS

    Time frame: 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.

  3. Heart rate

    Time frame: 2 hours after surgery when the subject has woken up

    Heart rate is monitored and recorded.

  4. Respiratory rate

    Time frame: 2 hours after surgery when the subject has woken up

    Respiratory rate is monitored and recorded.

  5. Oxygen saturation

    Time frame: 2 hours after surgery when the subject has woken up

    Oxygen saturation is monitored and recorded.

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Academy of Finland
  • Turku University Hospital

Registry information

Acronym: SPA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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