跳至主要内容
临床试验/NCT02571933
NCT02571933已完成不适用

Face Validity and Cross-Cultural Acceptability of the FPS-R in Cameroon

Cameroon Baptist Convention Health1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015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
36
试验地点
1
主要终点
Face validity of pain scale as assessed by cognitive interview probes

研究概览

简要总结

This study evaluates the face validity and cultural acceptability of the Faces Pain Scale - Revised in pediatric patients treated at Mbingo Baptist Hospital, Northwest Province, Cameroon. Participants from the four major language/cultural groups evaluated at the hospital with a complaint of pain will trial the Faces Pain Scale - Revised and then undergo cognitive interviewing to assess comprehension and clinical accuracy.

详细描述

Twelve to fifteen pediatric patients complaining of pain from each of the four primary language groups treated at Mbingo Baptist Hospital (Grammar English, Pidgin English, French, and Fulfulde) will be enrolled in the study. Each patient enrolled will trial the Faces Pain Scale - Revised (FPS-R) in his or her native tongue, before receiving standard analgesic treatment as ordered by the provider caring for the patient. One to two hours post analgesia, the patient will be reassessed and the FPS-R will be repeated. After completion of the second FPS-R, an audio-recorded cognitive interview will be performed by trained study personnel. These recordings will be transcribed into English and analyzed on a question-by-question basis to evaluate for themes pertaining to comprehension and understanding, ease of use, and reliability, within the different language groups. Enrollment in the study does not alter the routine pain management offered or received by patients. Rather, the FPS-R will be utilized on patients who are complaining of pain and who will be allocated to receive analgesia regardless of study enrollment.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Admitted to Children's Ward
  • •Complaint of pain

排除标准

  • •Traumatic brain injury
  • •Glasgow Coma Scale (GCS) < 13
  • •Cognitive delay
  • •Narcotic/opioid dependency

结局指标

主要结局

Face validity of pain scale as assessed by cognitive interview probes

时间窗: Through study completion, an average of 3 months

Detailed qualitative review of cognitive interview probes with question-by-question analysis of transcribed cognitive interviews to assess for basic comprehension and appropriate use of the FPS-R.

Face validity of pain scale as assessed by FPS-R results

时间窗: Through study completion, an average of 3 months

Detailed review of the FPS-R answers provided by patients in the context of their illness/injury.

Cultural acceptability of pain scale as assessed by cognitive interview probes

时间窗: Through study completion, an average of 3 months

Question-by-question analysis and review of transcribed cognitive interviews to search for thematic responses that correspond to cultural understanding and ease of use.

次要结局

未报告次要终点

研究者

发起方
Cameroon Baptist Convention Health
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验