Non-pharmacological Treatments for Non-malignant and Malignant Pain
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2019
CompletedFirst Submitted
Initial submission to the registry
January 2, 2020
CompletedFirst Posted
Study publicly available on registry
January 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2021
CompletedFebruary 10, 2020
February 1, 2020
1.3 years
January 2, 2020
February 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Change in pain description
The impact of slef-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).
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)
Change in sleep
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).
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)
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).
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)
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).
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)
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).
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)
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).
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)
Change in quality of life
The impact of self-hypnosis/self-care on the quality of life will be assessed by means of the "Short Form-36"(SF-36, Ware et al., 1988). Each item is balanced to obtain a score between 0 (worst quality) to 100 (maximum quality).
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)
Change in locus of control
The impact of self-hypnosis/self-care on the locus of control will be assessed my means og the "Multidimensional Health Locus of Control" (MHLC, Wallston et al., 1978). Scale ranging from 1 (no agreement) to 4 (agreement).
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)
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).
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)
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).
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)
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).
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)
Study Arms (4)
Self-hypnosis/self-care group
EXPERIMENTALIt 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 exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.
Music/self-care
EXPERIMENTALIt 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.
Self-hypnosis/self-care motivation
EXPERIMENTALIt 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 exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.
Self-hypnosis/self-care malignant pain
EXPERIMENTALIt 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 exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.
Interventions
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 exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.
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.
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 exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.
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 exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.
Eligibility Criteria
You may qualify if:
- Major
- Fluency in French
- Chronic pain diagnosis (malignant and non-malignant)
You may not qualify if:
- Neurologic disorder
- Psychiatric disorder
- Drug addiction
- Alcoholism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital University of Liège
Liège, 4000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 2, 2020
First Posted
January 3, 2020
Study Start
May 8, 2018
Primary Completion
September 10, 2019
Study Completion
January 30, 2021
Last Updated
February 10, 2020
Record last verified: 2020-02