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Treatment Comparison in Chronic Pain

Treatment Comparison in Chronic Pain : a Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04261530
Enrollment
644
Registered
2020-02-07
Start date
2015-03-17
Completion date
2018-05-08
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison of Different Treatment for Chronic Pain

Keywords

Chronic pain, Self-hypnosis, Self-care, Music-therapy, Psycho-education

Brief summary

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 of people suffering from chronic pain. Non-pharmacological techniques such as hypnosis, self-care learning, music-therapy and psycho-education 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 and self-care alone in order to highlight the most efficient treatment for chronic pain.

Interventions

BEHAVIORALMusic/self-care
BEHAVIORALSelf-care

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Each patients will have a medical consultation and will have to fill-in questionnaires (T0). After, the care staff will have a multidisciplinary discussion and will randomize the participants to different treatment groups : self-hypnosis/self-care, music/self-care, self-care and psycho-education. Another group will be included but will not be randomized because it includes patients who demand to learn self-hypnosis/self-care (group named self-hypnosis/self-care motivation). 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) or self-care or psycho-education 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Major * Fluency in French * Chronic pain diagnosis

Exclusion criteria

* Neurologic disorder * Psychiatric disorder * Drug addiction * Alcoholism

Design outcomes

Primary

MeasureTime frameDescription
Change in pain descriptionDay 0 (first meeting with the doctor), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up))The impact of self-hypnosis/self-care on pain description will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no pain) to 10 (worst pain).
Change in sleep difficultiesT0 (up to 5 month before inclusion), T1 (before the intervention), T2 (up to 8 months)The impact of self-hypnosis/self-care upon the severity of insomnia will be assessed by means of the Insomnia Severity Index (Morin et al., 2001). Scale ranging from 0 (none) to 4 (very severe).
Change in anxietyDay 0 (first meeting with the doctor), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)The impact of self-hypnosis/self-care on anxiety 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).
Change in depressionDay 0 (first meeting with the doctor), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)The impact of self-hypnosis/self-care on depression 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).
Change in pain disabilityDay 0 (first meeting with the doctor), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)The impact of self-hypnosis/self-care on pain disability 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).
Change in attitudes and beliefs about painDay 0 (first meeting with the doctor), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)The impact of self-hypnosis/self-care on the attitudes and beliefs about pain 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).
Change in quality of lifeDay 0 (first meeting with the doctor), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)The impact of self-hypnosis/self-care on the quality of life 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).
Change in locus of controlDay 0 (first meeting with the doctor), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)The impact of self-hypnosis/self-care on the locus of control 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).
Change of the impact of painDay 0 (first meeting with the doctor), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)The impact of self-hypnosis/self-care on the impact of pain in individual's life, quality of social support and general activity, will be assessed my means of the Multidimensional Pain Index (PDI, Kerns et al., 1985). Scale ranging from 0 (none) to 6 (a lot).
Change in generic healthDay 0 (first meeting with the doctor), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)The impact of self-hypnosis/self-care on generic health will be assessed by the EuroQol 5 Dimensions questionnaire (EQ-5D, Health Policy, 1990). Scale ranging from 1 (no problems) to 3 (extreme problems).
Change in health statusDay 0 (first meeting with the doctor), up to 7 months (right after the intervention), up to 13 months (6 months follow-up), up to 19 months (12 months follow-up)The impact of Self-hypnosis/self-care on global health status will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (worst health status) to 100 (best health status).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026