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Trial record 83 of 3404 for:    Recruiting, Not yet recruiting, Available Studies | Pain

Pain Detection Through Automated Video Analysis (FXPAL)

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ClinicalTrials.gov Identifier: NCT04011189
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Brief Summary:
FX Palo Alto Laboratory (FXPAL) has developed an algorithm for pain assessment based on automated video facial and body pose analysis. Through the collaboration with FXPAL, the investigators aim to assess the sensitivity of this algorithm in detecting pain in post-surgical patients.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Videotaping Other: Questionnaires Not Applicable

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.

This pilot study will be conducted on 20 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 refined algorithm can be subsequently evaluated with a larger group of patients undergoing different pain conditions, and could potentially be used in clinical practice as a tool to assess pain if found to be sensitive.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pain Detection Through Automated Video Analysis
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: Videotaping

Upon successful recruitment of the study, patients will be asked to complete 2 questionnaires and rate their pre-surgical pain on the numerical rating scale in the pre-anaesthetic evaluation clinic. Their face and body pose from a frontal view will be videotaped.

The general anaesthesia technique and type of analgesia administered intra-operatively will be according to standard practice and is at the discretion of the attending anaesthesiologist. After surgery, patients will be reviewed at 12-36 hrs, 36 hrs till before discharge post-operatively in the ward. They will be asked to rate their pain scores and videotaping will be done from a frontal view.

Procedure: 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 keypoints (70 points to capture key facial landmark locations and 25 points to capture joint locations), which will be the primary input for modeling algorithms and will further ensure anonymity of the patients in the video sequences.
Other Name: Videotaping via mobile phone

Other: Questionnaires
Patients will be asked to fill in two questionnaires before surgery (Hospital Anxiety and Depression Scale (HADS), EQ-5D-3L). After surgery, patients will be again asked to fill in HADS questionnaire daily post-operatively.
Other Name: Questionnaires (HADS, EQ-5D-3L)




Primary Outcome Measures :
  1. Change in Pain score [ Time Frame: Before surgery (1 day) and after surgery (1-2 days) ]
    Difference of Pain score before and after surgery. Pain scores (Numeric Rating Scale 0-10) will be asked, with zero being no pain, and 10 being the worst pain possible.

  2. Extracted key points from video [ Time Frame: Before surgery (1 day) and after surgery (1-2 days) ]
    The collected videos will be further processed to extract keypoints (70 points to capture key facial landmark locations and 25 points to capture joint locations), which will be the primary input for modeling 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 :
  1. Change in Hospital Anxiety and Depression Scale (HADS) score [ Time Frame: Before surgery (1 day) and after surgery (1-2 days) ]
    HADS Anxiety and Depression score before and after surgery. 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).

  2. EQ-5D-3L score [ Time Frame: Before surgery (1 day) ]
    EQ-5D-3L score before surgery. 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".



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females undergoing gynecologic surgery will be recruited.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing major gynaecological surgery;
  • Patients expected to be prescribed morphine patient controlled analgesia post-operatively;
  • American Society of Anaesthesiologists (ASA) physical status 1 or 2 patients.

Exclusion Criteria:

  • Pregnant patients;
  • Patients who are discharged <48 hours post-surgery;
  • Type of anaesthesia/post-operative analgesia:

    1. Surgery under neuraxial anaesthesia
    2. Not on morphine patient controlled analgesia post-operatively
  • 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
    4. Presence of chronic pain (> 3 months)
    5. On long term pain medications (> 3 months).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011189


Contacts
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Contact: Ban Leong Sng, FANZCA +6563941081 sng.ban.leong@singhealth.com.sg

Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
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Principal Investigator: John Lee, M Med KK Women's and Children's Hospital

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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT04011189     History of Changes
Other Study ID Numbers: ANAESPRG19/03
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KK Women's and Children's Hospital:
Postoperative pain
Automated video analysis
Pain score
Face recognition

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms