Facemasks and Chronic Pain Patients With Hearing Loss

January 23, 2025 updated by: Salem Anaesthesia Pain Clinic

Facemasks and COVID-19 Pandemic in Chronic Pain Patients With Hearing Impairment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Facemasks may impede communication. Impaired communication may worsen healthcare outcomes. There is inadequate data on the prevalence of hearing impairment in chronic pain patients. There is inadequate information about the impact of facemasks on treatment outcomes in chronic pain patients with hearing impairment. This prospective study explores the problem of hearing impairment in chronic pain patients, and the impact of facemasks on healthcare outcomes in chronic pain patients.

This is a prospective cohort study of adult patients undergoing pain treatment at an interventional pain clinic in Canada. Data collection includes patient's age, anxiety score, depression score, analgesic usage, numeric pain score, and effects of facemasks on pain management outcomes. Pain is measured using numeric pain rating scale of 0-10, with change of 2-points being considered significant. Depression is measured using the Patient Health Questionnaire (PHQ-9) scale of 0-27, with change of 3-points being considered significant. Anxiety is measured using the General Anxiety Disorder (GAD-7) scale of 0-21, with change of 3-points being considered significant.

Data are analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3S 7J1
        • Salem Anaesthesia Pain Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric pain score, objective measurement using validated Numeric Pain Rating scale
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression score, objective measurement using validated Patient Health Questionnaire (PHQ-9) scale
Time Frame: 12 weeks
Depression score, using the Patient Health Questionnaire (PHQ-9) scale of 0-27; low scores indicate less depression, high scores indicate worse depression
12 weeks
Anxiety score, objective measurement using validated General Anxiety Disorder (GAD-7) scale
Time Frame: 12 weeks
Anxiety score, using the General Anxiety Disorder (GAD-7) scale of 0-21; low scores indicate less anxiety, high scores indicate worse anxiety
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salem Anaesthesia Pain Clinic

Investigators

  • Principal Investigator: Olumuyiwa Bamgbade, MD,FRCPC, Salem Anaesthesia Pain Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

December 11, 2024

Study Completion (Actual)

December 11, 2024

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Salem2018 HearLoss Pain Mask

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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