Condition or disease | Intervention/treatment | Phase |
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Pain, Postoperative | Procedure: Videotaping Other: Questionnaires | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Pain Detection Through Automated Video Analysis |
Actual Study Start Date : | August 1, 2019 |
Actual Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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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)
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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 |
Inclusion Criteria:
Exclusion Criteria:
Type of anaesthesia/post-operative analgesia:
Medical problems/ medications:
Singapore | |
KK Women's and Children's Hospital | |
Singapore, Singapore, 229899 |
Principal Investigator: | John Lee, M Med | KK Women's and Children's Hospital |
Tracking Information | |||||||
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First Submitted Date ICMJE | July 4, 2019 | ||||||
First Posted Date ICMJE | July 8, 2019 | ||||||
Last Update Posted Date | February 9, 2021 | ||||||
Actual Study Start Date ICMJE | August 1, 2019 | ||||||
Actual Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Pain Detection Through Automated Video Analysis | ||||||
Official Title ICMJE | Pain Detection Through Automated Video Analysis | ||||||
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. | ||||||
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 ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Pain, Postoperative | ||||||
Intervention ICMJE |
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Study Arms ICMJE | 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. Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
28 | ||||||
Original Estimated Enrollment ICMJE |
20 | ||||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||
Actual Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Singapore | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04011189 | ||||||
Other Study ID Numbers ICMJE | ANAESPRG19/03 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | KK Women's and Children's Hospital | ||||||
Study Sponsor ICMJE | KK Women's and Children's Hospital | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | KK Women's and Children's Hospital | ||||||
Verification Date | February 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |