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临床试验/NCT04218227
NCT04218227已完成不适用

Dropout Factors in Chronic Pain Management : What Are the Predictors ?

University of Liege1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2019年3月1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
228
试验地点
1
主要终点
Amount of dropout between treatment groups

研究概览

简要总结

Chronic pain concernes one in four adults in Belgium. Because of the psychological and social repercussions, a biopsychosocial approach is necessary in order to improve the quality of life chronic pain patients. Non-pharmacological techniques such as hypnosis, self-care learning, music-therapy and psycho-education are gaining more and more interest in the scientific field. However, a major problem in clinical research is patient dropout. To our knowledge, no study has investigated dropout rates in hypnosis clinical research. The aim of this study is, therefore, to better understand the predictors of dropout in several non-pharmacological treatments in chronic pain management.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • Fluency in French
  • Chronic pain diagnosis

排除标准

  • Neurologic disorder
  • Psychiatric disorder
  • Drug addiction
  • Alcoholism

结局指标

主要结局

Amount of dropout between treatment groups

时间窗: T1 (before treatment)

The amount of drop-out between treatments group will be assessed by means of our database.

Influence of therapist's expertise in hypnosis

时间窗: T1 (before treatment)

The influence of the therapist's expertise in hypnosis upon drop-out will be assessed by means of our database.

Link between state-financial help and drop-out

时间窗: T1 (before treatment)

In Belgium, in certain cases, state will financially help patients to benefit from pain non-pharmacological treatments. We would like to understand if the benefit of state financial help influences the amount of drop-out.

Influence of pain description

时间窗: T1 (before treatment)

The influence of pain description upon dropout rates will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no pain) to 10 (worst pain).

Influence of anxiety

时间窗: T1 (before treatment)

The influence of anxiety upon dropout will be assessed by means of the subtest "anxiety" of the Hospital Anxiety and Depression Scale (HADS, Zigmond \& Snaith, 1983). Scale ranging from 0 (never) to 4 (always).

Influence of the impact of pain

时间窗: T1 (before treatment)

The influence of the impact of pain in individual's life, quality of social support and general activity, upon dropout will be assessed my means of the "Multidimensional Pain Index" (MPI, Kerns et al., 1985). Scale ranging from 0 (none) to 6 (a lot).

Influence of motivation

时间窗: T1 (before treatment)

To understand of motivation influenced the amount of drop-out, we analysed the amount of drop-out in the "self-hypnosis/self-care motivation" group.

Influence of insomnia

时间窗: T1 (before treatment)

The influence of the severity of insomnia upon dropout will be assessed by means of the "Insomnia Severity Index" (Morin et al., 2001). Scale ranging from 0 (none) to 4 (very severe).

Influence of locus of control

时间窗: T1 (before treatment)

The influence of the locus of control upon dropoout will be assessd my means og the "Multidimensional Health Locus of Control" (MHLC, Wallston et al., 1978). Scale ranging from 1 (no agreement) to 4 (agreement).

Amount of drop-out

时间窗: T1 (before treatment)

The amount of drop-out between treatments group will be assessed by means of our database.

Influence of sleep difficulties

时间窗: T1 (before treatment)

The influence of sleep difficulties upon dropout rates will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no sleep difficulties) to 10 (worst sleep difficulties).

Influence of depression

时间窗: T1 (before treatment)

The influence of depression upon dropout will be assessed by means of the subtest "anxiety" of the Hospital Anxiety and Depression Scale (HADS, Zigmond \& Snaith, 1983). Scale ranging from 0 (never) to 4 (always).

Influence of pain disability

时间窗: T1 (before treatment)

The influence of pain disability upon will be assessed by means of the "Pain Disability Index" (PDI, Tait et al., 1990). Scale ranging from 0 (no difficulties) to 10 (a lot of difficulties).

Influence of attitudes and beliefs about pain

时间窗: T1 (before treatment)

The influence of the attitudes and beliefs about pain upon dropout will be assessed my means of the "Survey of Pain Attitudes" (SOPA, Jensen \& Karoly, 1987). Scale ranging from 0 (totally wrong) to 10 (totally right).

Influence of quality of life

时间窗: T1 (before treatment)

The influence of quality of life upon dropout will be assessed by means of the "SF-36"(Ware et al., 1988). Each item is balanced to obtain a score between 0 (worst quality) to 100 (maximum quality).

次要结局

未报告次要终点

研究者

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

Audrey Vanhaudenhuyse

Principal Investigator

University of Liege

研究点 (1)

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