Comparison of Different Treatment for Chronic PainNCT04261530
Treatment Comparison in Chronic Pain
A study testing Self-hypnosis/self-care, Music/self-care and Self-care in people with Comparison of Different Treatment for Chronic Pain, run by University of Liege.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comparison of Different Treatment for Chronic Pain
- What is being tested?
- Self-hypnosis/self-care, Music/self-care and Self-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 644 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2015to 8 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major
- Fluency in French
- Chronic pain diagnosis
Who cannot join
- Neurologic disorder
- Psychiatric disorder
- Drug addiction
- Alcoholism
About this study
Official title: Treatment Comparison in Chronic Pain : a Randomized Study
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.
- Being tested
- Self-hypnosis/self-care, Music/self-care, Self-care, Psycho-education
- Keywords
- Chronic pain, Self-hypnosis, Self-care, Music-therapy, Psycho-education
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-hypnosis/self-careBehavioural
Music/self-careBehavioural
Self-careBehavioural
Psycho-educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Self-hypnosis/self-care group | Experimental | 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. Receives: Behavioral: Self-hypnosis/self-care |
| Music/self-care | Experimental | 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. Receives: Behavioral: Music/self-care |
| Self-care | Experimental | 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. Receives: Behavioral: Self-care |
| Psycho-education | Experimental | 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. Receives: Behavioral: Psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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))
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).
Measured: T0 (up to 5 month before inclusion), T1 (before the intervention), T2 (up to 8 months)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start17 Mar 2015
- Primary completion30 Mar 2016
- Study completion8 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of Different Treatment for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 644 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrey Vanhaudenhuyse, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261530
- Sponsor's protocol ID
- 2015/85
- Status last verified
- Apr 2021
- First submitted
- 21 Oct 2019
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Comparison in Chronic Pain : a Randomized Study
- ClinicalTrials.gov ID
- NCT04261530
- Acronym / sponsor ID
- 2015/85
- Keywords
- Chronic pain, Self-hypnosis, Self-care, Music-therapy, Psycho-education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 644 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 17 Mar 2015 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-hypnosis/self-care group | Experimental | Behavioral: Self-hypnosis/self-careIt 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. |
| Music/self-care | Experimental | Behavioral: Music/self-careIt 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-care | Experimental | Behavioral: Self-careIt 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. |
| Psycho-education | Experimental | Behavioral: Psycho-educationIt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major
- Fluency in French
- Chronic pain diagnosis
Key exclusion criteria (4 listed)
- Neurologic disorder
- Psychiatric disorder
- Drug addiction
- Alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-hypnosis/self-care | Behavioural | Self-hypnosis/self-care group |
| Music/self-care | Behavioural | Music/self-care |
| Self-care | Behavioural | Self-care |
| Psycho-education | Behavioural | Psycho-education |
Primary outcome
Change in pain description
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))
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 difficulties
Time frame: T0 (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 anxiety
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)
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 depression
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)
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 disability
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)
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 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)
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 life
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)
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 control
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)
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 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)
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 health
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)
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 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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Self-hypnosis/self-care, Music/self-care and Self-care in people with Comparison of Different Treatment for Chronic Pain, run by University of Liege.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain description (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))). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.