NCT06072235

Brief Summary

Facemasks may impede communication. Impaired communication may worsen healthcare outcomes. This study explores the problem of hearing impairment in chronic pain patients, and the impact of facemasks on healthcare outcomes in chronic pain patients. Data collection includes patient's age, anxiety score, depression score, numeric pain score, and effects of facemasks on treatment outcomes. Pain is measured using numeric pain rating scale. Depression is measured using the Patient Health Questionnaire (PHQ-9) scale. Anxiety is measured using the General Anxiety Disorder (GAD-7) scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2024

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

6.9 years

First QC Date

October 2, 2023

Last Update Submit

January 23, 2025

Conditions

Hearing LossChronic Pain

Outcome Measures

Primary Outcomes (1)

  • Numeric pain score, objective measurement using validated Numeric Pain Rating scale

    Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain

    12 weeks

Secondary Outcomes (2)

  • Depression score, objective measurement using validated Patient Health Questionnaire (PHQ-9) scale

    12 weeks

  • Anxiety score, objective measurement using validated General Anxiety Disorder (GAD-7) scale

    12 weeks

Interventions

Verbal communicationBEHAVIORAL

Verbal communication; by talking and listening

Eligibility Criteria

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

A cohort of consecutive adult patients who underwent pain management at a pain clinic

You may qualify if:

  • adults
  • chronic pain diagnosis
  • diagnosed hearing impairment
  • use of hearing aid

You may not qualify if:

  • complete deafness
  • cochlear implant
  • severe vision impairment
  • cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

Location

MeSH Terms

Conditions

Hearing LossChronic Pain

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Study Officials

  • Olumuyiwa Bamgbade, MD,FRCPC

    Salem Anaesthesia Pain Clinic

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 10, 2023

Study Start

January 8, 2018

Primary Completion

December 11, 2024

Study Completion

December 11, 2024

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)