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临床试验/NCT03112759
NCT03112759已完成不适用

Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis

University of Louisville2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2017年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Presence and severity of abdominal pain

研究概览

简要总结

This study will assess cognitive behavioral therapy as an adjunct to conventional symptom control for patients with chronic pancreatitis.

详细描述

All patients with chronic pancreatitis will be considered for participation in this study. Patients selected for participation will be evaluated 4 weeks prior to the first one-on-one therapy session. A baseline pain score will be assessed using the visual analog pain scale. Narcotic dosage and frequency as well as anti-emetic usage will be evaluated at this time. A pre-treatment quality of life score will be recorded using the SF-12® Patient Questionnaire. Patients will also be queried about the presence of nausea and reflux.

After the pre-intervention evaluations are complete, patients will be randomized into one of two arms: treatment with cognitive behavioral therapy and narcotics as needed or treatment with conventional narcotic analgesics alone. Patients undergoing CBT intervention will participate in eight weekly therapy sessions. Follow-up assessments will be conducted six months and nine months after the last therapy session is completed. The patients will be evaluated based on pain score, narcotic dosage and frequency, anti-emetic usage, quality of life assessment, and pain related hospitalizations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Patient must be18 years of age
  • Diagnosed with chronic pancreatitis
  • Willing and able to comply with the protocol requirements
  • Able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study

排除标准

  • Participating in another clinical trial for the treatment of chronic pancreatitis at the time of screening

结局指标

主要结局

Presence and severity of abdominal pain

时间窗: 1 year

A visual analog scale will be used to measure patients pain pre- and post- intervention

次要结局

  • Quality of Life(1 year)
  • Narcotic Usage(1 year)
  • Presence and Severity of Nausea and Reflux(1 year)
  • Hospitalizations(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gary C. Vitale, MD

General Surgeon, Professor of medicine

University of Louisville

研究点 (2)

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