Patient ViolenceNCT05938101
Pain Clinic Staff Harassed by Patients Pre/Post COVID
An observational study of Patient Violence, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
Trial summary
Chronic pain may cause psychological or behavioral problems. Chronic pain patients occasionally harass the pain care providers. The COVID-19 pandemic caused major stress for the general population. Quantitative and qualitative analysis of prospective electronic and clinic diary data. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Violence
- What is being tested?
- Behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult chronic pain patients who are undergoing treatment in a specialist pain clinic
Who may be able to join
- adult chronic pain patients
Who cannot join
- pediatric chronic pain patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Salem Anaesthesia Pain Clinic
Surrey, British Columbia, V3S 7J1
Olumuyiwa Bamgbade, MD, FRCPC, +17786286600, salem.painclinic@gmail.com
About this study
Official title: Pain Clinic Staff Harassment Caused by Patients Pre/Post COVID Pandemic
Chronic pain may cause psychological or behavioral problems. Chronic pain patients occasionally harass the pain care providers. The COVID-19 pandemic caused major stress for the general population.
Quantitative and qualitative analysis of prospective electronic and clinic diary data. Evaluation of incidents of clinic staff harassment; caused by patients, before and during COVID pandemic. Analysis of causative factors, incident outcome and lessons learned.
Read the detailed description
Chronic pain may be complicated by mental disease. Some patients have behavioral disorders and occasionally harass the pain care providers. The COVID-19 pandemic caused significant stress for the general population. The stress of the pandemic may aggravate the psychological dysfunction in chronic pain patients.
This is a quantitative and qualitative analysis of prospective electronic and clinic diary data. It is an evaluation of incidents of pain clinic staff harassment; caused by patients, before and during the COVID pandemic. This is an analysis of incident causative factors, incident outcomes, systemic factors and lessons learned. The qualitative information of each incident is presented in a sensitive and careful format.
- Conditions
- Patient Violence
- Being tested
- Behavioral therapy
- Keywords
- Harassment by patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral therapyBehavioural
Behavioral therapy and psychotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who harassed clinic staff
Percentage of patients who harassed clinic staff
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start2 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salem Anaesthesia Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olu Bamgbade, MD,FRCPC, Principal investigator, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938101
- Sponsor's protocol ID
- Salem2021 Harass PrePst COVID
- Status last verified
- Jan 2025
- First submitted
- 6 Jul 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caruso R, Toffanin T, Folesani F, Biancosino B, Romagnolo F, Riba MB, McFarland D, Palagini L, Belvederi Murri M, Zerbinati L, Grassi L. Violence Against Physicians in the Workplace: Trends, Causes, Consequences, and Strategies for Intervention. Curr Psychiatry Rep. 2022 Dec;24(12):911-924. doi: 10.1007/s11920-022-01398-1. Epub 2022 Nov 29.
PubMed 36445636
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Clinic Staff Harassment Caused by Patients Pre/Post COVID Pandemic
- ClinicalTrials.gov ID
- NCT05938101
- Acronym / sponsor ID
- Salem2021 Harass PrePst COVID
- Conditions
- Patient Violence
- Keywords
- Harassment by patient
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Salem Anaesthesia Pain ClinicUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pain may cause psychological or behavioral problems. Chronic pain patients occasionally harass the pain care providers. The COVID-19 pandemic caused major stress for the general population.
Quantitative and qualitative analysis of prospective electronic and clinic diary data. Evaluation of incidents of clinic staff harassment; caused by patients, before and during COVID pandemic. Analysis of causative factors, incident outcome and lessons learned.
Detailed description
Chronic pain may be complicated by mental disease. Some patients have behavioral disorders and occasionally harass the pain care providers. The COVID-19 pandemic caused significant stress for the general population. The stress of the pandemic may aggravate the psychological dysfunction in chronic pain patients.
This is a quantitative and qualitative analysis of prospective electronic and clinic diary data. It is an evaluation of incidents of pain clinic staff harassment; caused by patients, before and during the COVID pandemic. This is an analysis of incident causative factors, incident outcomes, systemic factors and lessons learned. The qualitative information of each incident is presented in a sensitive and careful format.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult chronic pain patients who are undergoing treatment in a specialist pain clinic
Key inclusion criteria (1 listed)
- adult chronic pain patients
Key exclusion criteria (1 listed)
- pediatric chronic pain patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral therapyBehavioral therapy and psychotherapy | Behavioural | – |
Primary outcome
Percentage of patients who harassed clinic staff
Time frame: 12 months
Percentage of patients who harassed clinic staff
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Background: PubMed 36445636Caruso R, Toffanin T, Folesani F, Biancosino B, Romagnolo F, Riba MB, McFarland D, Palagini L, Belvederi Murri M, Zerbinati L, Grassi L. Violence Against Physicians in the Workplace: Trends, Causes, Consequences, and Strategies for Intervention. Curr Psychiatry Rep. 2022 Dec;24(12):911-924. doi: 10.1007/s11920-022-01398-1. Epub 2022 Nov 29.
- Individual participant dataSharing planned: No
Related trials for Patient Violence
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RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
Intimate Partner Violence (IPV)
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Factors of Effectiveness in Italian Forensic Treatment
Forensic Psychiatric Patients, Not Guilty by Reason of Insanity (NGRI)
Recruiting
HVIP Outcomes and Stakeholder Insights
Firearm Injury, Violence, Physical
Enrolling by invitation
Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan
Trauma and Stressor Related Disorders, Violence, Structural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olu Bamgbade, MD,FRCPC principal investigator
Salem Anaesthesia Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Violence, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olu Bamgbade, MD,FRCPC (17786286600, salem.painclinic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who harassed clinic staff (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05938101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.