Pain, PostoperativeNCT02316951
Monitoring Postoperative Pain and Recovery Following Orthopedic Surgery
An observational study of Pain, Postoperative, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- single-arm study group
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2015to 7 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (age >21) recovering from orthopedic surgery residing in an area hospital and under the care of the acute pain service.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- single-arm study group
- Keywords
- Postoperative, Pain, Symptoms, Video recording, Orthopedic surgery
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-arm study groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: single-arm study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study start9 Jul 2015
- Primary completion7 Aug 2022
- Study completion7 Aug 2022
Why it stopped: Logistical and enrollment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Tighe, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316951
- Sponsor's protocol ID
- IRB201400424
- Status last verified
- May 2023
- First submitted
- 10 Dec 2014
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Postoperative Pain and Recovery Following Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT02316951
- Acronym / sponsor ID
- IRB201400424
- Conditions
- Pain, Postoperative
- Keywords
- Postoperative, Pain, Symptoms, Video recording, Orthopedic surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Logistical and enrollment issues
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 9 Jul 2015 (actual)
- Primary completion
- 7 Aug 2022 (actual)
- Study completion
- 7 Aug 2022 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm study group | – | Device: single-arm study groupStudy 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age >21) recovering from orthopedic surgery residing in an area hospital and under the care of the acute pain service.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single-arm study groupStudy 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. | Device | single-arm study group |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Logistical and enrollment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Tighe, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Logistical and enrollment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain assessment (Correlate pain scores with motion measurements obtained through measurement of movement activity and video.) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.