Facemasks and Chronic Pain Patients With Hearing Loss

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06072235
• Other study ID #: Salem2018 HearLoss Pain Mask
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: May 11, 2024

Study information

• Verified date: October 2023
• Source: Salem Anaesthesia Pain Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 11, 2024
• Est. primary completion date: May 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• adults

• chronic pain diagnosis

• diagnosed hearing impairment

• use of hearing aid

Exclusion Criteria:

• complete deafness

• cochlear implant

• severe vision impairment

• cognitive dysfunction

Related Conditions & MeSH terms

• Chronic Pain
• Deafness
• Hearing Loss

Intervention

Behavioral:
• Verbal communication
Verbal communication; by talking and listening

Locations

Country	Name	City	State
Canada	Salem Anaesthesia Pain Clinic	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Salem Anaesthesia Pain Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Depression score, objective measurement using validated Patient Health Questionnaire (PHQ-9) scale	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
Secondary	Anxiety score, objective measurement using validated General Anxiety Disorder (GAD-7) scale	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