Facemasks and Chronic Pain Patients With Hearing Loss

Sponsor
Salem Anaesthesia Pain Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT06072235
Collaborator
(none)
1,000
1
70.1
14.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Verbal communication

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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Facemasks and COVID-19 Pandemic in Chronic Pain Patients With Hearing Impairment
Actual Study Start Date :
Jan 8, 2018
Anticipated Primary Completion Date :
Nov 11, 2023
Anticipated Study Completion Date :
Nov 11, 2023

Outcome Measures

Primary Outcome Measures

  1. Numeric pain score, objective measurement using validated Numeric Pain Rating scale [12 weeks]

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

Secondary Outcome Measures

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

  2. Anxiety score, objective measurement using validated General Anxiety Disorder (GAD-7) scale [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • adults

  • chronic pain diagnosis

  • diagnosed hearing impairment

  • use of hearing aid

Exclusion Criteria:
  • complete deafness

  • cochlear implant

  • severe vision impairment

  • cognitive dysfunction

Contacts and Locations

Locations

Site City State Country Postal Code
1 Salem Anaesthesia Pain Clinic Surrey British Columbia Canada V3S 7J1

Sponsors and Collaborators

  • Salem Anaesthesia Pain Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Salem Anaesthesia Pain Clinic
ClinicalTrials.gov Identifier:
NCT06072235
Other Study ID Numbers:
  • Salem2018 HearLoss Pain Mask
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023