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Completed

NCT Number: NCT04218227

Dropout Factors in Chronic Pain Management

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital University of Liège

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Major
  • Fluency in French
  • Chronic pain diagnosis

Exclusion criteria

  • Neurologic disorder
  • Psychiatric disorder
  • Drug addiction
  • Alcoholism

Treatment and study plan

Self-hypnosis/self-care group

Behavioral

Self-hypnosis/self-care

Music/self-care

Behavioral

Music-therapy/self-care

self-care

Behavioral

Self-care

Psycho-education

Behavioral

Psycho-education

Self-hypnosis/self-care motivation

Behavioral

Motivation to learn self-hypnosis/self-care

Primary outcomes

  1. Amount of drop-out

    Time frame: T1 (before treatment)

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

  2. Amount of dropout between treatment groups

    Time frame: T1 (before treatment)

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

  3. Influence of therapist's expertise in hypnosis

    Time frame: T1 (before treatment)

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

  4. Link between state-financial help and drop-out

    Time frame: 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.

  5. Influence of motivation

    Time frame: 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.

  6. Influence of pain description

    Time frame: 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).

  7. Influence of sleep difficulties

    Time frame: 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).

  8. Influence of insomnia

    Time frame: 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).

  9. Influence of anxiety

    Time frame: 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).

  10. Influence of depression

    Time frame: 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).

  11. Influence of pain disability

    Time frame: 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).

  12. Influence of the impact of pain

    Time frame: 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).

  13. Influence of attitudes and beliefs about pain

    Time frame: 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).

  14. Influence of quality of life

    Time frame: 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).

  15. Influence of locus of control

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 6, 2020
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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