Dropout Factors in Chronic Pain Management

Chronic Pain Clinical Trial

Official title:

Dropout Factors in Chronic Pain Management : What Are the Predictors ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218227
• Other study ID #: 2015/85-C
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: February 6, 2020

Study information

• Verified date: March 2022
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: February 6, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major

• Fluency in French

• Chronic pain diagnosis

Exclusion Criteria:

• Neurologic disorder

• Psychiatric disorder

• Drug addiction

• Alcoholism

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Self-hypnosis/self-care group
Self-hypnosis/self-care
• Music/self-care
Music-therapy/self-care
• Self-care
Self-care
• Psycho-education
Psycho-education
• Self-hypnosis/self-care motivation
Motivation to learn self-hypnosis/self-care

Locations

Country	Name	City	State
Belgium	Hospital University of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of drop-out	The amount of drop-out between treatments group will be assessed by means of our database.	T1 (before treatment)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)