Monitoring Postoperative Pain and Recovery Following Orthopedic Surgery

May 24, 2023 updated by: University of Florida
This pilot study will seek to use emotion recognition technology from video to link patient facial expressions, heart rate and respiratory rate changes, and movement patterns to patient pain scores.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

During hospitalization, beginning after orthopedic surgery, study participants will be asked to wear a small motion detector on their wrist. A computer vision system which analyzes both whole-body movement as well as facial expressions will be used at the bedside to compare common signs and symptoms of post op pain to patient pain scores.

Up to 30 study participants will be selected.

Study participants will be asked to complete a written pain diary during waking hours.This information will be compared to the pain scores found in the patient's medical record and/or the amount and frequency of pain medications they receive.

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (age >21) recovering from orthopedic surgery residing in an area hospital and under the care of the acute pain service.

Description

Inclusion Criteria:

  • Recovery following Orthopedic Surgery
  • Non-vulnerable adult patient
  • Residing on the 6th floor of the South Tower of UF Health Shands Hospital
  • Under the care of the acute pain service

Exclusion Criteria:

  • Inability to understand pain assessments
  • Inability to wear a motion tracking device
  • Amputation of limb
  • Vulnerable subject status
  • Anticipated discharge from hospital within 24 hours following enrollment
  • < 21 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single-arm study group
Study participants will be adult patients recovering from orthopedic surgery. The study group will wear a small motion detection device and a regular Webcam will be placed near the wall facing the bed in each patient's hospital room.
Device: single-arm study group
Study participants will wear a small motion detection device and a regular Webcam will be placed near the wall facing the bed in each patient's hospital room. Study participants will be questioned about their sociodemographic, pain, and health history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain assessment (Correlate pain scores with motion measurements obtained through measurement of movement activity and video.)
Time Frame: 1 day
Correlate pain scores with motion measurements obtained through measurement of movement activity and video.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Patrick Tighe, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2015

Primary Completion (Actual)

August 7, 2022

Study Completion (Actual)

August 7, 2022

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (Estimated)

December 15, 2014

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201400424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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