Hearing LossNCT06072235
Facemasks and Chronic Pain Patients With Hearing Loss
An observational study of Hearing Loss and Chronic Pain, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Chronic Pain
- What is being tested?
- Verbal communication
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2018to 11 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A cohort of consecutive adult patients who underwent pain management at a pain clinic
Who may be able to join
- adults
- chronic pain diagnosis
- diagnosed hearing impairment
- use of hearing aid
Who cannot join
- complete deafness
- cochlear implant
- severe vision impairment
- cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss, Chronic Pain
- Being tested
- Verbal communication
- Medical subject headings
- Hearing Loss, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal communicationBehavioural
Verbal communication; by talking and listening
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (2)
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
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start8 Jan 2018
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salem Anaesthesia Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olumuyiwa Bamgbade, MD,FRCPC, Principal investigator, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072235
- Sponsor's protocol ID
- Salem2018 HearLoss Pain Mask
- Status last verified
- Jan 2025
- First submitted
- 2 Oct 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facemasks and COVID-19 Pandemic in Chronic Pain Patients With Hearing Impairment
- ClinicalTrials.gov ID
- NCT06072235
- Acronym / sponsor ID
- Salem2018 HearLoss Pain Mask
- Conditions
- Hearing Loss, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Salem Anaesthesia Pain ClinicUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of consecutive adult patients who underwent pain management at a pain clinic
Key inclusion criteria (4 listed)
- adults
- chronic pain diagnosis
- diagnosed hearing impairment
- use of hearing aid
Key exclusion criteria (4 listed)
- complete deafness
- cochlear implant
- severe vision impairment
- cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal communicationVerbal communication; by talking and listening | Behavioural | – |
Primary outcome
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
2 secondary outcomes
Depression score, objective measurement using validated Patient Health Questionnaire (PHQ-9) scale
Time frame: 12 weeks
Anxiety score, objective measurement using validated General Anxiety Disorder (GAD-7) scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olumuyiwa Bamgbade, MD,FRCPC principal investigator
Salem Anaesthesia Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Chronic Pain, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain score, objective measurement using validated Numeric Pain Rating scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.