Harassment of Pain Clinic Staff by Patients | NCT05876104

Studies
Harassment of Pain Clinic Staff by Patients

NCT05876104

Sponsor

Salem Anaesthesia Pain Clinic

Status

Completed

Last Update Posted

May 14, 2024Actual

Enrollment

1,102Actual

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

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2018Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

May 11, 2023

First Submission Date that Met QC Criteria

May 16, 2023

First Posted Date

May 25, 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

May 11, 2024

Last Update Posted Date

May 14, 2024Actual

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 is associated with psychological disorders, and many patients have behavioral problems. Some patients harass pain services staff. Most healthcare staff do not report harassment by patients.

Quantitative and qualitative analysis of prospective electronic and clinic diary data. Evaluation of incidents of clinic staff harassment; caused by patients and patients' family. Analysis of causative factors, incident outcome and lessons learned.

Detailed Description

Chronic pain is associated with psychological and mental health disorders. Many patients have personality and behavioral disorders. Some patients harass their pain care providers. Most healthcare staff do not report harassment by 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 and patients' family. This is an analysis of incident causative factors, incident outcome 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

1,102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult chronic pain patients		Adult chronic pain patients who harass pain clinic staff	Behavioral: Behavioral therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Behavioral therapy	Behavioral	Behavioral and supportive therapy	Adult chronic pain patients

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

Not provided

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		Surrey	British Columbia	V3S 7J1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26037534	Background	David K, Anuj D, Nabil S. Violence toward chronic pain care providers: A national survey. Pain Med. 2015 Oct;16(10):1882-96. doi: 10.1111/pme.12794. Epub 2015 Jun 2.
35112665	Background	Bamgbade OA, Tai-Osagbemi J, Bamgbade DO, Murphy-Akpieyi O, Fadire A, Soni NK, Mumporeze L. Clonidine is better than zopiclone for insomnia treatment in chronic pain patients. J Clin Sleep Med. 2022 Jun 1;18(6):1565-1571. doi: 10.5664/jcsm.9930.

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities