Clinical trial NCT06072235: Facemasks and Chronic Pain Patients With Hearing Loss
Official title: Facemasks and COVID-19 Pandemic in Chronic Pain Patients With Hearing Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Chronic Pain
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of consecutive adult patients who underwent pain management at a pain clinic

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Numeric pain score, objective measurement using validated Numeric Pain Rating scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Depression score, objective measurement using validated Patient Health Questionnaire (PHQ-9) scale
timeFrame: 12 weeks
measure: Anxiety score, objective measurement using validated General Anxiety Disorder (GAD-7) scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olumuyiwa Bamgbade, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: