Clinical trial NCT04217681: Non-pharmacological Treatments for Non-malignant and Malignant Pain
Official title: Non-pharmacological Treatments (Self-hypnosis/Self-care and Music-therapy) for Non-malignant and Malignant Pain : a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Comparison of Treatment for Chronic Non-malignant and Malignant Pain
Keywords: chronic pain
cancer
self-hypnosis
self-care
music-therapy
motivation
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patients will have a medical consultation and will have to fill-in questionnaires (T0). After, patients will have to participate in a 5-session psycho-education programme. After, the care staff will have a multidisciplinary discussion and will randomize the participants to different treatment groups : self-hypnosis/self-care and music/self-care. Another group will be included but will not be randomized because it includes patients who demand to learn self-hypnosis/self-care (non-malignant and malignant pain). After, participants will receive a 7 months (2 hours session a month) learning program of self-hypnosis/self-care animated by a therapist specialized in hypnosis or music/self-care (identical procedure but the hypnosis is replaced by music) at the end if which they will complete the same questionnaire (T2). A follow-up at 6 (T3) and 12 (T4) months will also be conducted to account for any long term effect.
Primary purpose: TREATMENT

Brief summary: Chronic pain concerns 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 of people suffering from chronic pain. Non-pharmacological techniques such as hypnosis, self-care learning and music-therapy are gaining more and more interest in the scientific field. Indeed, several studies have shown a reduction in psychological distress and an improvement in global quality of life after having learned self-hypnosis/self-care. Furthermore, other studies focusing on music as a treatment for chronic pain highlight an analgesic effect of music over pain and a reduction of common comorbidities. Nevertheless, only few studies aim at comparing these techniques to each other. The aim of our study would be to compare a 7 months learning program of self-hypnosis/self-care, music-therapy/self-care, motivation to learn self-hypnosis/self-care in order to highlight the most efficient treatment for chronic pain. Furthermore, we will include another type of chronic pain i.e. cancer pain to understand if self-hypnosis/self-care's impact is different in the other type of chronic pain.


Eligibility criteria: Inclusion Criteria:

* Major
* Fluency in French
* Chronic pain diagnosis (malignant and non-malignant)

Exclusion Criteria:

* Neurologic disorder
* Psychiatric disorder
* Drug addiction
* Alcoholism

Primary outcomes:
measure: Change in pain description
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
measure: Change in sleep
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
measure: Change in anxiety
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
measure: Change in depression
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
measure: Change in pain disability
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
measure: Change in attitudes and beliefs about pain
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
measure: Change in quality of life
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
measure: Change in locus of control
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
measure: Change of the impact of pain
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
measure: Change in generic health
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
measure: Change in health status
timeFrame: Day 0 (before the intervention), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Hospital University of Liège
Study officials:
References: