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

NCT ID: NCT04263324

Last Updated: 2020-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-03-30

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Self-hypnosis/self-care

Intervention Type BEHAVIORAL

Learning phase of self-hypnosis/self-care.

Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self-hypnosis/self-care

Learning phase of self-hypnosis/self-care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Major
* Fluency in French
* Fibromyalgia diagnosis

Exclusion Criteria

* Neurologic disorder
* Psychiatric disorder
* Drug addiction
* Alcoholism
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Benoit

UNKNOWN

Sponsor Role collaborator

University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Audrey Vanhaudenhuyse

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital University of Liège

Liège, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Audrey Vanhaudenhuyse, PhD

Role: CONTACT

+3243668482

Aminata Bicego, PhD Student

Role: CONTACT

+3243663499

Facility Contacts

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Audrey Vanhaudenhuyse, PhD

Role: primary

+3243668482

Aminata Bicego, PhD Student

Role: backup

+3243663499

References

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Kumar Govindaiah P, Adarsh A, Panda R, Gosseries O, Malaise N, Salamun I, Tshibanda L, Laureys S, Bonhomme V, Faymonville ME, Vanhaudenhuyse A, Bicego A. Exploring Electrophysiological Responses to Hypnosis in Patients with Fibromyalgia. Brain Sci. 2024 Oct 23;14(11):1047. doi: 10.3390/brainsci14111047.

Reference Type DERIVED
PMID: 39595811 (View on PubMed)

Other Identifiers

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2017/291

Identifier Type: -

Identifier Source: org_study_id

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