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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04263324
Enrollment
60
Registered
2020-02-10
Start date
2019-09-01
Completion date
2020-03-30
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

chronic pain, fibromyalgia, hypnosis, fMRI, EEG

Brief summary

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).

Interventions

Learning phase of self-hypnosis/self-care.

Sponsors

Fondation Benoit
CollaboratorUNKNOWN
University of Liege
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Each patients will have a medical and a psychological consultation and will have to fill-in questionnaires (T0). Then, they will receive a psycho-education training (5 sessions) and will have to complete the same questionnaires (T1). After that, they will again have a medical (pain doctor) and a psychological consultation. Afterwards, the care staff will have a multidisciplinary discussion about their diagnosis. Then functional Magnetic Resonance Imaging (fMRI; 1 hour) and HdEEG (1 hour) data will be acquired in resting state. After that, participants will receive a 7 months (2 hours session a month) learning program of self-hypnosis/self-care animated by a therapist specialized in hypnosis. After the 7 months learning-program they will complete the same questionnaires (T2) and be scanned again by means of fMRI and HdEEG. Patient who do not want to participate to the learning program will not have a treatment but will be scanned in the fMRI and the HdEEG.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Major * Fluency in French * Fibromyalgia diagnosis

Exclusion criteria

* Neurologic disorder * Psychiatric disorder * Drug addiction * Alcoholism

Design outcomes

Primary

MeasureTime frameDescription
Change in pain descriptionDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change in sleep difficultiesDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change in anxietyDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change in depressionDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change in pain disabilityDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change in attitudes and beliefs about painDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change in quality of lifeDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change in locus of controlDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change of the impact of painDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change in generic healthDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change in health statusDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Change in physical activityDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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.
Motivation to changeDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).
Impact on return-to-workDay 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)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).

Countries

Belgium

Contacts

Primary ContactAudrey Vanhaudenhuyse, PhD
avanhaudenhuyse@chuliege.be+3243668482
Backup ContactAminata Bicego, PhD Student
abicego@uliege.be+3243663499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026