Chronic PainNCT04218227
Dropout Factors in Chronic Pain Management
An observational study of Chronic Pain, run by University of Liege at 1 site in Belgium.
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 chronic pain patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Self-hypnosis/self-care group, Music/self-care and Self-care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 228 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 6 Feb 2020
- Phase
- Observational
- 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
Study population: Patients must have had a chronic pain diagnosis (all body-parts and all type of pain included) and must have been included in one of the outpatient chronic pain non-pharmacological management programme with an interdisciplinary approach proper to our pain department at the Hospital University of Liège (Belgium).
Who may be able to join
- Major
- Fluency in French
- Chronic pain diagnosis
Who cannot join
- Neurologic disorder
- Psychiatric disorder
- Drug addiction
- Alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dropout Factors in Chronic Pain Management : What Are the Predictors ?
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 chronic pain patients. Non-pharmacological techniques such as hypnosis, self-care learning, music-therapy and psycho-education are gaining more and more interest in the scientific field. However, a major problem in clinical research is patient dropout. To our knowledge, no study has investigated dropout rates in hypnosis clinical research. The aim of this study is, therefore, to better understand the predictors of dropout in several non-pharmacological treatments in chronic pain management.
- Conditions
- Chronic Pain
- Being tested
- Self-hypnosis/self-care group, Music/self-care, Self-care, Psycho-education, Self-hypnosis/self-care motivation
- 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-care groupBehavioural
Self-hypnosis/self-care
Music/self-careBehavioural
Music-therapy/self-care
Self-careBehavioural
Self-care
Psycho-educationBehavioural
Psycho-education
Self-hypnosis/self-care motivationBehavioural
Motivation to learn self-hypnosis/self-care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-hypnosis/self-care group | |
| 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. Receives: Behavioral: Music/self-care | |
| 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. Receives: Behavioral: Self-care | |
| 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. Receives: Behavioral: Psycho-education | |
| Self-hypnosis/self-care motivation | 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 motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of drop-out
The amount of drop-out between treatments group will be assessed by means of our database.
Measured: T1 (before treatment)
Amount of dropout between treatment groups
The amount of drop-out between treatments group will be assessed by means of our database.
Measured: T1 (before treatment)
Influence of therapist's expertise in hypnosis
The influence of the therapist's expertise in hypnosis upon drop-out will be assessed by means of our database.
Measured: T1 (before treatment)
Link between state-financial help and drop-out
In Belgium, in certain cases, state will financially help patients to benefit from pain non-pharmacological treatments. We would like to understand if the benefit of state financial help influences the amount of drop-out.
Measured: T1 (before treatment)
Influence of motivation
To understand of motivation influenced the amount of drop-out, we analysed the amount of drop-out in the "self-hypnosis/self-care motivation" group.
Measured: T1 (before treatment)
Influence of pain description
The influence of pain description upon dropout rates will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no pain) to 10 (worst pain).
Measured: T1 (before treatment)
Influence of sleep difficulties
The influence of sleep difficulties upon dropout rates will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no sleep difficulties) to 10 (worst sleep difficulties).
Measured: T1 (before treatment)
Influence of insomnia
The influence of the severity of insomnia upon dropout will be assessed by means of the "Insomnia Severity Index" (Morin et al., 2001). Scale ranging from 0 (none) to 4 (very severe).
Measured: T1 (before treatment)
Influence of anxiety
The influence of anxiety upon dropout 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: T1 (before treatment)
Influence of depression
The influence of depression upon dropout 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: T1 (before treatment)
Influence of pain disability
The influence of pain disability upon 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: T1 (before treatment)
Influence of the impact of pain
The influence of the impact of pain in individual's life, quality of social support and general activity, upon dropout will be assessed my means of the "Multidimensional Pain Index" (MPI, Kerns et al., 1985). Scale ranging from 0 (none) to 6 (a lot).
Measured: T1 (before treatment)
Influence of attitudes and beliefs about pain
The influence of the attitudes and beliefs about pain upon dropout 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: T1 (before treatment)
Influence of quality of life
The influence of quality of life upon dropout 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: T1 (before treatment)
Influence of locus of control
The influence of the locus of control upon dropoout 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: T1 (before treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Mar 2019
- Primary completion1 Sep 2019
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 228 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
- NCT04218227
- Sponsor's protocol ID
- 2015/85-C
- Status last verified
- Mar 2022
- First submitted
- 2 Jan 2020
- Last updated
- 4 Apr 2022
- 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 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dropout Factors in Chronic Pain Management : What Are the Predictors ?
- ClinicalTrials.gov ID
- NCT04218227
- Acronym / sponsor ID
- 2015/85-C
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 6 Jan 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 chronic pain patients. Non-pharmacological techniques such as hypnosis, self-care learning, music-therapy and psycho-education are gaining more and more interest in the scientific field. However, a major problem in clinical research is patient dropout. To our knowledge, no study has investigated dropout rates in hypnosis clinical research. The aim of this study is, therefore, to better understand the predictors of dropout in several non-pharmacological treatments in chronic pain management.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Self-hypnosis/self-care group | – | Behavioral: Self-hypnosis/self-care groupIt 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 | – | 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 | – | Behavioral: 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. |
| Psycho-education | – | 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. |
| Self-hypnosis/self-care motivation | – | Behavioral: Self-hypnosis/self-care motivationIt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must have had a chronic pain diagnosis (all body-parts and all type of pain included) and must have been included in one of the outpatient chronic pain non-pharmacological management programme with an interdisciplinary approach proper to our pain department at the Hospital University of Liège (Belgium).
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 groupSelf-hypnosis/self-care | Behavioural | Self-hypnosis/self-care group |
| Music/self-careMusic-therapy/self-care | Behavioural | Music/self-care |
| Self-careSelf-care | Behavioural | Self-care |
| Psycho-educationPsycho-education | Behavioural | Psycho-education |
| Self-hypnosis/self-care motivationMotivation to learn self-hypnosis/self-care | Behavioural | Self-hypnosis/self-care motivation |
Primary outcome
Amount of drop-out
Time frame: T1 (before treatment)
The amount of drop-out between treatments group will be assessed by means of our database.
Amount of dropout between treatment groups
Time frame: T1 (before treatment)
The amount of drop-out between treatments group will be assessed by means of our database.
Influence of therapist's expertise in hypnosis
Time frame: T1 (before treatment)
The influence of the therapist's expertise in hypnosis upon drop-out will be assessed by means of our database.
Link between state-financial help and drop-out
Time frame: T1 (before treatment)
In Belgium, in certain cases, state will financially help patients to benefit from pain non-pharmacological treatments. We would like to understand if the benefit of state financial help influences the amount of drop-out.
Influence of motivation
Time frame: T1 (before treatment)
To understand of motivation influenced the amount of drop-out, we analysed the amount of drop-out in the "self-hypnosis/self-care motivation" group.
Influence of pain description
Time frame: T1 (before treatment)
The influence of pain description upon dropout rates will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no pain) to 10 (worst pain).
Influence of sleep difficulties
Time frame: T1 (before treatment)
The influence of sleep difficulties upon dropout rates will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no sleep difficulties) to 10 (worst sleep difficulties).
Influence of insomnia
Time frame: T1 (before treatment)
The influence of the severity of insomnia upon dropout will be assessed by means of the "Insomnia Severity Index" (Morin et al., 2001). Scale ranging from 0 (none) to 4 (very severe).
Influence of anxiety
Time frame: T1 (before treatment)
The influence of anxiety upon dropout 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).
Influence of depression
Time frame: T1 (before treatment)
The influence of depression upon dropout 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).
Influence of pain disability
Time frame: T1 (before treatment)
The influence of pain disability upon 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).
Influence of the impact of pain
Time frame: T1 (before treatment)
The influence of the impact of pain in individual's life, quality of social support and general activity, upon dropout will be assessed my means of the "Multidimensional Pain Index" (MPI, Kerns et al., 1985). Scale ranging from 0 (none) to 6 (a lot).
Influence of attitudes and beliefs about pain
Time frame: T1 (before treatment)
The influence of the attitudes and beliefs about pain upon dropout 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).
Influence of quality of life
Time frame: T1 (before treatment)
The influence of quality of life upon dropout 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).
Influence of locus of control
Time frame: T1 (before treatment)
The influence of the locus of control upon dropoout 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).
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 4 Apr 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by University of Liege at 1 site in Belgium.
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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Amount of drop-out (time frame: T1 (before treatment)). The study lists 15 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 4 Apr 2022.