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临床试验/NCT01001039
NCT01001039已完成不适用

Validation of the FAcial and CEphalic PAin INventory (FACE PAIN)

Greg Davis1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1

研究概览

简要总结

This study proposes to develop and validate a new instrument designed to measure facial and nasal discomfort related to chronic sinusitis. The second phase of the study will be to use this instrument to measure correlation with sinus computed tomography (CT) scans.

详细描述

The following specific aims will be addressed:

  • to create a user-friendly, self-explanatory instrument (FACE PAIN questionnaire) with pain severity visual analog scales associated with the common locations of facial pain in chronic sinusitis.
  • to evaluate the clinimetric reliability and validity of the FACE PAIN questionnaire
  • to evaluate the ability of th FACE PAIN questionnaire to detect change in symptoms following medical or surgical treatment
  • to quantify a minimally important difference in the FACE PAIN instrument by correlating disease-specific quality of life change (Transition Scale) with FACE PAIN rating changes following treatment.
  • to evaluate the correlation between facial pain symptoms described on the FACE PAIN questionnaire with CT scan and endoscopic findings.

The measurements used for the study are: demographics (age, gender and race), contact information (to facilitate mailing of future instruments), Sinonasal Outcome Test-20 (SNOT-20 - a well validated, 20-item measure of rhinosinusitis specific QOL), FAcial and CEphalic PAin INventory (instrument under study) and Translational Quality of Life Form (this transition scale provides a subjective quantification of the degree of change in quality of life from sinusitis); CT scans and nasal endoscopy findings.

Control subjects will complete the SNOT-20 (validated QOL form) and the FACE PAIN a single time.

Case subjects will complete the SNOT-20 and the FACE PAIN questionnaire at the visit during which they review their CT results with the MD. Thereafter, they will complete the FACE PAIN questionaire twice more; at weeks 12 and 14 post that visit. They will also complete the Transition Scale at week 12. These forms will be mailed to the subjects and returned by mail.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Case subjects from the Rhinology Clinic must have CT evidence of chronic sinusitis
  • Control subject from the Otology Clinic who have not had sinus surgery in the past 2 months

排除标准

  • any subject unable to give informed consent of complete self-administered questionnaires written in English
  • Control subjects with a history of sinusitis in the last 6 months

研究者

发起方
Greg Davis
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Greg Davis

Assistant Professor

University of Washington

研究点 (1)

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