跳至主要内容
临床试验/NCT06072235
NCT06072235已完成不适用

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

Salem Anaesthesia Pain Clinic1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
Numeric pain score, objective measurement using validated Numeric Pain Rating scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Numeric pain score, objective measurement using validated Numeric Pain Rating scale

时间窗: 12 weeks

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

次要结局

  • Anxiety score, objective measurement using validated General Anxiety Disorder (GAD-7) scale(12 weeks)
  • Depression score, objective measurement using validated Patient Health Questionnaire (PHQ-9) scale(12 weeks)

研究者

发起方
Salem Anaesthesia Pain Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验