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Pain Detection Through Automated Video Analysis

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Videotaping
Questionnaires
Empatica E4 wristband
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Postoperative pain, Automated video analysis, Pain score, Face recognition

Eligibility Criteria

6 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Phases 1, 2:

  • Patients undergoing surgical and pain procedures, inpatient and outpatient consultations
  • American Society of Anaesthesiologists (ASA) physical status 1, 2 or 3 (ASA 1, 2 or 3) patients

Phase 3: Male children undergoing laser circumcision in day surgery

Exclusion Criteria

Phases 1, 2:

  • Pregnant patients;
  • Medical problems/ medications:

    1. Psychiatric disorders (e.g. anxiety, depression)
    2. Neurological disorders (e.g. Cerebrovascular accident, Parkinson's Disease)
    3. Musculoskeletal limitations that result in gait abnormalities/limitations

Phase 3:

  • Developmental delay/ cognitive impairment
  • Autism Spectrum disorder
  • Attention-deficit/hyperactivity disorder
  • Excessive anxiety or requires sedative premed
  • Chronic pain conditions and/or medication
  • Previous traumatic pain experience

Sites / Locations

  • KK Women's and Children's HospitalRecruiting
  • Singapore General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Videotaping

Arm Description

First phase: Patients will complete questionnaire, pain score in pre-anaesthetic clinic. Their face and body pose are videotaped. Patients are reviewed on pain scores with videotaping at 12-36 hrs, 36 hrs till before discharge post-operatively. Second phase: Patients will complete questionnaires, pain score, videotaping in pre-operative/-procedural/inpatient/outpatient consultation waiting areas. After surgery/procedure/consultation, i) Surgery: Patients rate pain scores with videotaping at 12-36 hrs, 36 hrs till before discharge. ii) Procedure: Patients are asked on questionnaire, pain score, videotaping. iii) Consultation: Patients are asked on questionnaire, pain score, videotaping on next consultation. Third phase: Patients will complete questionnaire and pain score in preoperative areas. They are videotaped while wearing a physiological wristband to monitor heart rate and body temperature. After surgery, pain score is rated while being videotaped with wristband.

Outcomes

Primary Outcome Measures

Change in Pain score
Difference of Pain score before and after surgery/procedure/consultation. Pain scores (Numeric Rating Scale 0-10) will be asked, with zero being no pain, and 10 being the worst pain possible.
Extracted key points from video
The collected videos will be further processed to extract key points, which will be the primary input for modelling algorithms and will further ensure anonymity of the patients in the video sequences. This will then be used for pain score prediction by correlated to outcome 1 (patients' reported pain score).

Secondary Outcome Measures

Change in Hospital Anxiety and Depression Scale (HADS) score
HADS Anxiety and Depression score before and after surgery/procedure/consultation. HADS is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. For each subscore (anxiety/depression), 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); and 11-21 = Abnormal (case).
EQ-5D-3L score
EQ-5D-3L score before surgery/procedure/consultation. EQ-5D-3L is a standardized instrument for measuring generic health status. It is made up for two components; health state description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves an analogue scale, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine".
Child Pain Anxiety Symptoms Scale (CPASS) score
CPASS score before surgery. The CPASS is a 20-item scale to evaluate pain anxiety in children. For each item, children are asked to rate the extent to which they think, act, or feel that way on a scale from 0 ("never think, act or feel that way") to 5 ("always think, act, or feel that way"). Total scores range from 0 to 100, with higher scores indicating higher levels of pain anxiety.

Full Information

First Posted
July 4, 2019
Last Updated
August 8, 2023
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04011189
Brief Title
Pain Detection Through Automated Video Analysis
Official Title
Pain Detection Through Automated Video Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study team has developed an algorithm for pain assessment based on automated video facial and body pose analysis. The investigators aim to assess the sensitivity of this algorithm in detecting pain in post-surgical patients and refine the algorithm to increase the sensitivity of pain detection in patients.
Detailed Description
Post-surgical pain, if inadequately controlled, has deleterious short and long term consequences for the patient. Although most patients are able to report their pain scores, a minority are unable to do so and assessing their pain can prove to be a challenge for healthcare professionals. In recent years, facial recognition tools have been developed based on the premise that subtle facial variations signifies pain. However, changes in body, and head posture can also represent pain. As such, these tools are with their limitations and are only validated on certain groups of patients, thus may not be sensitive enough to detect pain in post-surgical patients. The first stage of the study will be conducted on 40 patients presenting for major gynaecological surgery, with the obtained data used to fine tune the algorithm. The patients will be video-taped pre-surgically in the pre-evaluation anaesthetic clinic and post-surgically in the ward. They will be asked to rate their pain scores on the numerical rating scale and fill in questionnaires on their psychological and quality of health status. The pain scores will be correlated with the results obtained from the pain assessment algorithm. The second phase will improve and enhance the model by (1) analysing body pose to improve the model performance; (2) validating the improved model by recruiting 200 patients undergoing surgical and pain procedures, inpatient and outpatient consultations to collect their videos before and after surgery and inpatient and outpatient pain consultations; (3) integrate the model into a standalone electronic application to improve its usability in both inpatient and outpatient settings. The third phase will recruit 130 male paediatric patients presenting for circumcision surgery to improve algorithm by i) Adding body posture analysis and other physiological measurement to further improve the performance of our model; ii) Developing our model for use in the pediatric population; and iii) Improving its usability in both clinical and non-clinical settings. Deidentified keypoints will be extracted from the videos to further validate the model.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Postoperative pain, Automated video analysis, Pain score, Face recognition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Videotaping
Arm Type
Experimental
Arm Description
First phase: Patients will complete questionnaire, pain score in pre-anaesthetic clinic. Their face and body pose are videotaped. Patients are reviewed on pain scores with videotaping at 12-36 hrs, 36 hrs till before discharge post-operatively. Second phase: Patients will complete questionnaires, pain score, videotaping in pre-operative/-procedural/inpatient/outpatient consultation waiting areas. After surgery/procedure/consultation, i) Surgery: Patients rate pain scores with videotaping at 12-36 hrs, 36 hrs till before discharge. ii) Procedure: Patients are asked on questionnaire, pain score, videotaping. iii) Consultation: Patients are asked on questionnaire, pain score, videotaping on next consultation. Third phase: Patients will complete questionnaire and pain score in preoperative areas. They are videotaped while wearing a physiological wristband to monitor heart rate and body temperature. After surgery, pain score is rated while being videotaped with wristband.
Intervention Type
Procedure
Intervention Name(s)
Videotaping
Other Intervention Name(s)
Videotaping via mobile phone
Intervention Description
Before the videotaping, patients will be asked on their baseline pain scores. Their face and body pose from a frontal view will be videotaped via a mobile phone with no internet access. The collected videos will be further processed to extract key points, which will be the primary input for modelling algorithms and will further ensure anonymity of the patients in the video sequences.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Questionnaires (HADS, EQ-5D-3L or CPASS)
Intervention Description
Patients will be asked to fill in 1-2 questionnaires before surgery/procedure/consultation (Hospital Anxiety and Depression Scale (HADS) and/or EQ-5D-3L). After surgery/procedure/consultation, patients will be again asked to fill in HADS questionnaire (optional). For pediatrics patient, only Child Pain Anxiety Symptoms Scale (CPASS) will be administered before the surgery.
Intervention Type
Device
Intervention Name(s)
Empatica E4 wristband
Intervention Description
A medical grade wearable device, Empatica E4 wristband, will be used in phase 3 for pediatrics patients to monitor real-time physiological data on heart rate and body temperature.
Primary Outcome Measure Information:
Title
Change in Pain score
Description
Difference of Pain score before and after surgery/procedure/consultation. Pain scores (Numeric Rating Scale 0-10) will be asked, with zero being no pain, and 10 being the worst pain possible.
Time Frame
Before surgery/procedure/consultation (1 day) and after surgery/procedure/consultation(1-3 days)
Title
Extracted key points from video
Description
The collected videos will be further processed to extract key points, which will be the primary input for modelling algorithms and will further ensure anonymity of the patients in the video sequences. This will then be used for pain score prediction by correlated to outcome 1 (patients' reported pain score).
Time Frame
Before surgery/procedure/consultation (1 day) and after surgery/procedure/consultation(1-3 days)
Secondary Outcome Measure Information:
Title
Change in Hospital Anxiety and Depression Scale (HADS) score
Description
HADS Anxiety and Depression score before and after surgery/procedure/consultation. HADS is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. For each subscore (anxiety/depression), 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); and 11-21 = Abnormal (case).
Time Frame
Before surgery/procedure/consultation (1 day) and after surgery/procedure/consultation(1-3 days)
Title
EQ-5D-3L score
Description
EQ-5D-3L score before surgery/procedure/consultation. EQ-5D-3L is a standardized instrument for measuring generic health status. It is made up for two components; health state description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves an analogue scale, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine".
Time Frame
Before surgery/procedure/consultation (1 day)
Title
Child Pain Anxiety Symptoms Scale (CPASS) score
Description
CPASS score before surgery. The CPASS is a 20-item scale to evaluate pain anxiety in children. For each item, children are asked to rate the extent to which they think, act, or feel that way on a scale from 0 ("never think, act or feel that way") to 5 ("always think, act, or feel that way"). Total scores range from 0 to 100, with higher scores indicating higher levels of pain anxiety.
Time Frame
Before surgery/procedure/consultation (1 day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Phases 1, 2: Patients undergoing surgical and pain procedures, inpatient and outpatient consultations American Society of Anaesthesiologists (ASA) physical status 1, 2 or 3 (ASA 1, 2 or 3) patients Phase 3: Male children undergoing laser circumcision in day surgery Exclusion Criteria Phases 1, 2: Pregnant patients; Medical problems/ medications: Psychiatric disorders (e.g. anxiety, depression) Neurological disorders (e.g. Cerebrovascular accident, Parkinson's Disease) Musculoskeletal limitations that result in gait abnormalities/limitations Phase 3: Developmental delay/ cognitive impairment Autism Spectrum disorder Attention-deficit/hyperactivity disorder Excessive anxiety or requires sedative premed Chronic pain conditions and/or medication Previous traumatic pain experience
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ban Leong Sng, FANZCA
Phone
+6563941081
Email
sng.ban.leong@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ban Leong Sng, FANZCA
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ban Leong Sng, FANZCA
Phone
+6563941081
Email
sng.ban.leong@singhealth.com.sg
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan Diana

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Lee M, Kennedy L, Girgensohn A, Wilcox L, Lee JS, Tan CW, Sng BL. Pain Intensity Estimation from Mobile Video Using 2D and 3D Facial Keypoints. arXiv preprint arXiv:2006.12246. 2020 Jun 17.
Results Reference
result
Links:
URL
https://arxiv.org/abs/2006.12246
Description
Pain Intensity Estimation from Mobile Video Using 2D and 3D Facial Keypoints

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Pain Detection Through Automated Video Analysis

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