NCT02316951

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

July 9, 2015

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2022

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

7.1 years

First QC Date

December 10, 2014

Last Update Submit

May 24, 2023

Conditions

Keywords

PostoperativePainSymptomsVideo recordingOrthopedic surgery

Outcome Measures

Primary Outcomes (1)

  • pain assessment (Correlate pain scores with motion measurements obtained through measurement of movement activity and video.)

    Correlate pain scores with motion measurements obtained through measurement of movement activity and video.

    1 day

Study Arms (1)

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

Interventions

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.

single-arm study group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Patrick Tighe, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 15, 2014

Study Start

July 9, 2015

Primary Completion

August 7, 2022

Study Completion

August 7, 2022

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations