NCT05945719

Brief Summary

Chronic pain is associated with mental disorders, and some patients have behavioral issues. Some patients may sexually or racially harass pain clinic staff. Healthcare staff do not usually report sexual or racial harassment perpetrated by patients. Quantitative and qualitative analysis of prospective electronic and clinic diary data. Evaluation of incidents of sexual and racial harassment of clinic staff; perpetrated by patients. Analysis of causative factors, incident outcome, system factors and lessons learned.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

8.2 years

First QC Date

July 6, 2023

Last Update Submit

January 23, 2025

Conditions

Keywords

Harassment by patients

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who sexually or racially harassed clinic staff

    Percentage of patients who sexually or racially harassed clinic staff

    12 months

Study Arms (1)

Adult chronic pain patients

Adult chronic pain patients who sexually harass pain clinic staff

Behavioral: Behavioral therapy

Interventions

Behavioral and supportive therapy

Adult chronic pain patients

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • adult chronic pain patients

You may not qualify if:

  • pediatric chronic pain patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

RECRUITING

Related Publications (1)

  • Adler M, Vincent-Hoper S, Vaupel C, Gregersen S, Schablon A, Nienhaus A. Sexual Harassment by Patients, Clients, and Residents: Investigating Its Prevalence, Frequency and Associations with Impaired Well-Being among Social and Healthcare Workers in Germany. Int J Environ Res Public Health. 2021 May 13;18(10):5198. doi: 10.3390/ijerph18105198.

    PMID: 34068346BACKGROUND

MeSH Terms

Conditions

CoitusOccupational Stress

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorOccupational DiseasesStress, PsychologicalBehavioral Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Olu Bamgbade

    Salem Anaesthesia Pain Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olu Bamgbade, MD,FRCPC

CONTACT

Olumuyiwa Bamgbade, MD,FRCPC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 14, 2023

Study Start

November 1, 2017

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations