Pain Detection Through Automated Video Analysis

NCT04011189 | Active Not Recruiting

• 1 other identifier: 2019/2293
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain, Postoperative

Keywords

Postoperative pain; Automated video analysis; Pain score; Face recognition

Outcome Measures

Primary Outcomes (2)

• 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.

  Before surgery/procedure/consultation (1 day) and after surgery/procedure/consultation(1-3 days)

• 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).

  Before surgery/procedure/consultation (1 day) and after surgery/procedure/consultation(1-3 days)

Secondary Outcomes (3)

• Change in Hospital Anxiety and Depression Scale (HADS) score

  Before surgery/procedure/consultation (1 day) and after surgery/procedure/consultation(1-3 days)

• EQ-5D-3L score

  Before surgery/procedure/consultation (1 day)

• Child Pain Anxiety Symptoms Scale (CPASS) score

  Before surgery/procedure/consultation (1 day)

Study Arms (1)

Videotaping

EXPERIMENTAL

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.

Procedure: Videotaping; Other: Questionnaires; Device: Empatica E4 wristband

Interventions

Videotaping PROCEDURE

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.

Also known as: Videotaping via mobile phone

Videotaping

Questionnaires OTHER

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.

Also known as: Questionnaires (HADS, EQ-5D-3L or CPASS)

Videotaping

Empatica E4 wristband DEVICE

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.

Videotaping

Eligibility Criteria

• Age: 6 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (2)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

Related Publications (1)

• 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.

  RESULT

Related Links

• Pain Intensity Estimation from Mobile Video Using 2D and 3D Facial Keypoints

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Surveys and Questionnaires; 4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ban Leong Sng, FANZCA

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 8, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)