Dropout Factors in Chronic Pain Management
1 other identifier
observational
228
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Shorter than P25 for all trials
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
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 2, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2020
CompletedApril 4, 2022
March 1, 2022
6 months
January 2, 2020
March 22, 2022
Conditions
Outcome Measures
Primary Outcomes (15)
Amount of drop-out
The amount of drop-out between treatments group will be assessed by means of our database.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
T1 (before treatment)
Study Arms (5)
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.
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.
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.
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.
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.
Interventions
Motivation to learn self-hypnosis/self-care
Eligibility Criteria
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).
You may qualify if:
- Major
- Fluency in French
- Chronic pain diagnosis
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 2, 2020
First Posted
January 6, 2020
Study Start
March 1, 2019
Primary Completion
September 1, 2019
Study Completion
February 6, 2020
Last Updated
April 4, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share