Pain Detection Through Automated Video Analysis

NCT ID: NCT04011189

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2026-12-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Videotaping

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.

Group Type: EXPERIMENTAL

Videotaping

Intervention Type: 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.

Questionnaires

Intervention Type: 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.

Empatica E4 wristband

Intervention Type: 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.

Interventions

Videotaping

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: PROCEDURE

Questionnaires

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: OTHER

Empatica E4 wristband

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.

Intervention Type: DEVICE

Other Intervention Names

Videotaping via mobile phone; Questionnaires (HADS, EQ-5D-3L or CPASS)

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:

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ban Leong Sng, FANZCA

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: RESULT

Related Links

https://arxiv.org/abs/2006.12246

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

Other Identifiers

2019/2293

Identifier Type: -

Identifier Source: org_study_id