Pain Clinic Staff Harassed by Patients Pre/Post COVID | NCT05938101

Studies
Pain Clinic Staff Harassed by Patients Pre/Post COVID

NCT05938101

Sponsor

Salem Anaesthesia Pain Clinic

Status

Recruiting

Last Update Posted

Jan 27, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Patient Violence

Interventions

Behavioral therapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2020Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jul 6, 2023

First Submission Date that Met QC Criteria

Jul 6, 2023

First Posted Date

Jul 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2025

Last Update Posted Date

Jan 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Behavioral therapy	Behavioral	Behavioral therapy and psychotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients who harassed clinic staff	Percentage of patients who harassed clinic staff	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult chronic pain patients

Exclusion Criteria:

pediatric chronic pain patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Adult chronic pain patients who are undergoing treatment in a specialist pain clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Olu Bamgbade, MD,FRCPC	Contact	17786286600		salem.painclinic@gmail.com
Olumuyiwa Bamgbade, MD,FRCPC	Contact	17786286600		salem.painclinic@gmail.com

Overall Officials

Name	Affiliation	Role
Olu Bamgbade, MD,FRCPC	Salem Anaesthesia Pain Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Salem Anaesthesia Pain Clinic	Recruiting	Surrey	British Columbia	V3S 7J1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36445636	Background	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.

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities