Beneficial Effects of Self-hypnosis/Self-care for Chronic Pain Patients : a MRI and EEG Study

Beneficial Effects of Self-hypnosis/Self-care Learning Program for Chronic Pain Patients : a MRI and EEG Study

Chronic pain concerns one in four adults in Belgium. Fibromyalgia is an example of chronic pain and is characterized by diffused and migrant musculo-tendinous pain localized in the limbs and at an axial level. The technological improvement in neuroimaging allowed to improve, at a cerebral level, the identification of the structural and the functional characteristics of this clinical entity. Studies indicated a modification in cerebral morphometry showing an alteration of white and grey matter in the anterior cingulate cortex, orbitofrontal lateral cortex, cerebellum, basal ganglia, insula, secondary somatosensory cortex, thalamus, amygdala, putamen, superior temporal gyrus and periaqueductal grey matter. At a functional level, studies show un alteration in the connectivity of the default mode network, an atrophy of zones implicated in nociception and an increased activation of zone implicated in response to a nociceptive stimulus.

Nowadays, researchers are interested in finding out the beneficial effects of non-pharmacological techniques to improve de well-being of patients with chronic pain. Hypnosis is one of these techniques that has already proven to be successful in decreasing pain and improving global quality of life. Nevertheless, to our knowledge, no study has been conducted to understand the impact of hypnosis upon the cerebral functioning of these patients. Therefore, the aim of this study is to understand the impact of a 6 months self-hypnosis/self-care learning program upon the structural and functional functioning of the brain by means of functional magnetic resonance imagery (fMRI) and electroencephalography (EEG).

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Self-hypnosis/self-care

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • 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

Description

Inclusion Criteria:

• Major
• Fluency in French
• Fibromyalgia diagnosis

Exclusion Criteria:

• Neurologic disorder
• Psychiatric disorder
• Drug addiction
• Alcoholism

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention
Experimental: 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 exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.	Behavioral: Self-hypnosis/self-care; Learning phase of self-hypnosis/self-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
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).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
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).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
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).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
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).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
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).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in quality of life	The impact of self-hypnosis/self-care on the quality of life will be assessed by means of the "Short Form-36"(SF-36; Ware et al., 1988). Each item is balanced to obtain a score between 0 (worst quality) to 100 (maximum quality).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in locus of control	The impact of self-hypnosis/self-care on the locus of control will be assessed my means og the "Multidimensional Health Locus of Control" (MHLC, Wallston et al., 1978). Scale ranging from 1 (no agreement) to 4 (agreement).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
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).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
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).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
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).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in physical activity	The impact of self-hypnosis/self-care on the physical activity will be assessed by means of the International Physical Activity Questionnaire (Craig et al., 2003). Participants have to describe the amount of low to intense physical activity they did over a period of 7 days.	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Motivation to change	The impact of self-hypnosis/self-care on the motivation to change will be assessed by means of the "University of Rhode Island Change Assessment" (URICA, DiClemente et al., 1990). Scale ranging from 1 (no agreement) to 5 (agreement).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Impact on return-to-work	For participants who continued to work at time of inclusion, the "Work Design Questionnaire" (WDQ, Morgeson & Hymphrey, 2006) will be administered. Scale ranging from 0 (not at all) to 5 (exactly).	Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

Collaborators and Investigators

• Sponsor: University of Liege
• Collaborators: Fondation Benoit

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): January 31, 2020
• Study Completion (Anticipated): March 30, 2020

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: chronic pain; fibromyalgia; fMRI; EEG; hypnosis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2017/291

Drug and device information, study documents

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