Dropout Factors in Chronic Pain Management

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Self-hypnosis/self-care group
* Behavioral: Music/self-care
* Behavioral: Self-care
* Behavioral: Psycho-education
* Behavioral: Self-hypnosis/self-care motivation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major Fluency in French Chronic pain diagnosis Exclusion Criteria: Neurologic disorder Psychiatric disorder Drug addiction Alcoholism

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Self-hypnosis/self-care group<br>It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercice is conducted at the end of each session. A CD with the audiotaped hypnosis exercice is given to each patient so that they can practice also every day. | Behavioral: Self-hypnosis/self-care group<br>* Self-hypnosis/self-care<br>|
| Music/self-care<br>It is a 7-months 2 hours-session (1 session per month) of music/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. At the end of each session, patients are invited to listen to a relaxing melody of 15 minutes. This melody was composed by a professional musico-therapist. A CD with the audiotaped melody is given to each patient so that they can practice also every day. | Behavioral: Music/self-care<br>* Music-therapy/self-care<br>|
| Self-care<br>It is a 7-months 2 hours-session (1 session per month) of music/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. | Behavioral: Self-care<br>* Self-care<br>|
| Psycho-education<br>It is a 7-months 2 hours-session (1 session per month) of psycho-education training. Psycho-education aims to empower and encourage the patient to become an actor in his therapeutic management, while offering a comprehensive model of the mechanisms of pain, the benefits of pharmacological treatments at a physical and psychological level as well as ways to change the way one lives every day. | Behavioral: Psycho-education<br>* Psycho-education<br>|
| Self-hypnosis/self-care motivation<br>It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercice is conducted at the end of each session. A CD with the audiotaped hypnosis exercice is given to each patient so that they can practice also every day. | Behavioral: Self-hypnosis/self-care motivation<br>* Motivation to learn self-hypnosis/self-care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of drop-out | The amount of drop-out between treatments group will be assessed by means of our database. | T1 (before treatment) | 
| Amount of dropout between treatment groups | The amount of drop-out between treatments group will be assessed by means of our database. | T1 (before treatment) | 
| Influence of therapist's expertise in hypnosis | The influence of the therapist's expertise in hypnosis upon drop-out will be assessed by means of our database. | T1 (before treatment) | 
| Link between state-financial help and drop-out | 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. | T1 (before treatment) | 
| Influence of motivation | 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. | T1 (before treatment) | 
| Influence of pain description | 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). | T1 (before treatment) | 
| Influence of sleep difficulties | 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). | T1 (before treatment) | 
| Influence of insomnia | 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). | T1 (before treatment) | 
| Influence of anxiety | 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). | T1 (before treatment) | 
| Influence of depression | 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). | T1 (before treatment) | 
| Influence of pain disability | 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). | T1 (before treatment) | 
| Influence of the impact of pain | 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). | T1 (before treatment) | 
| Influence of attitudes and beliefs about pain | 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). | T1 (before treatment) | 
| Influence of quality of life | 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). | T1 (before treatment) | 
| Influence of locus of control | 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). | T1 (before treatment) |