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CompletedNCT04261530Updated Apr 26, 2021

Treatment Comparison in Chronic Pain

An interventional study of Self-hypnosis/self-care and Music/self-care in Comparison of Different Treatment for Chronic Pain, sponsored by University of Liege. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-26.

Sponsored by University of Liege · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 7 months after the study started (first participant enrolled Mar 2015, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
644
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Comparison of Different Treatment for Chronic Pain

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Keywords

  • Chronic pain
  • Self-hypnosis
  • Self-care
  • Music-therapy
  • Psycho-education
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 644 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

University of Liege is the lead sponsor of 242 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Major
  • Fluency in French
  • Chronic pain diagnosis

Exclusion criteria

Exclusion Criteria:

  • Neurologic disorder
  • Psychiatric disorder
  • Drug addiction
  • Alcoholism
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
644 participants (actual)

Study arms

  • Experimental
    Self-hypnosis/self-care group

    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

  • Experimental
    Music/self-care

    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

  • Experimental
    Self-care

    It is a 7-months 2 hours-session (1 session per month) of 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

  • Experimental
    Psycho-education

    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

Interventions

  • BehavioralSelf-hypnosis/self-care
  • BehavioralMusic/self-care
  • BehavioralSelf-care
  • BehavioralPsycho-education
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What researchers measure

Primary outcomes

  1. Change in pain description

    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).

    Time frame: Day 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))

  2. Change in sleep difficulties

    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).

    Time frame: T0 (up to 5 month before inclusion), T1 (before the intervention), T2 (up to 8 months)

  3. Change in anxiety

    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).

    Time frame: Day 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)

  4. Change in depression

    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).

    Time frame: Day 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)

  5. Change in pain disability

    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).

    Time frame: Day 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)

  6. Change in attitudes and beliefs about pain

    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).

    Time frame: Day 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)

  7. Change in quality of life

    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).

    Time frame: Day 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)

  8. Change in locus of control

    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).

    Time frame: Day 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)

  9. Change of the impact of pain

    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).

    Time frame: Day 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)

  10. Change in generic health

    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).

    Time frame: Day 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)

  11. Change in health status

    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).

    Time frame: Day 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)

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04261530
Lead sponsor
University of Liege
Responsible party
Audrey Vanhaudenhuyse (Principal Investigator, University of Liege) — Principal investigator
First posted
Feb 7, 2020
Start date
Mar 17, 2015
Primary completion
Mar 30, 2016
Completion
May 8, 2018
Last update
Apr 26, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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