Dropout Factors in Chronic Pain Management

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Self-hypnosis/self-care group; Behavioral: Music/self-care; Behavioral: Self-care; Behavioral: Psycho-education; Behavioral: Self-hypnosis/self-care motivation

• Study Type: Observational
• Enrollment (Actual): 228

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Hospital University of Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

• Major
• Fluency in French
• Chronic pain diagnosis

Exclusion Criteria:

• Neurologic disorder
• Psychiatric disorder
• Drug addiction
• Alcoholism

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 group; Self-hypnosis/self-care
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; Music-therapy/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.	Behavioral: Self-care; 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.	Behavioral: Psycho-education; 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.	Behavioral: Self-hypnosis/self-care motivation; Motivation to learn self-hypnosis/self-care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): February 6, 2020

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2015/85-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No