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

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Self-hypnosis/self-care
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, fibromyalgia, hypnosis, fMRI, EEG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major
  • Fluency in French
  • Fibromyalgia diagnosis

Exclusion Criteria:

  • Neurologic disorder
  • Psychiatric disorder
  • Drug addiction
  • Alcoholism

Sites / Locations

  • Hospital University of LiègeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-hypnosis/self-care group

Control group

Arm Description

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.

No intervention

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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).
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).

Secondary Outcome Measures

Full Information

First Posted
January 2, 2020
Last Updated
February 6, 2020
Sponsor
University of Liege
Collaborators
Fondation Benoit
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1. Study Identification

Unique Protocol Identification Number
NCT04263324
Brief Title
Beneficial Effects of Self-hypnosis/Self-care for Chronic Pain Patients : a MRI and EEG Study
Official Title
Beneficial Effects of Self-hypnosis/Self-care Learning Program for Chronic Pain Patients : a MRI and EEG Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
Fondation Benoit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, fibromyalgia, hypnosis, fMRI, EEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-hypnosis/self-care group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Self-hypnosis/self-care
Intervention Description
Learning phase of self-hypnosis/self-care.
Primary Outcome Measure Information:
Title
Change in pain description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change in sleep difficulties
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change in anxiety
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change in depression
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change in pain disability
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change in attitudes and beliefs about pain
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change in quality of life
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change in locus of control
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change of the impact of pain
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change in generic health
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change in health status
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Change in physical activity
Description
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.
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Motivation to change
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Title
Impact on return-to-work
Description
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).
Time Frame
Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major Fluency in French Fibromyalgia diagnosis Exclusion Criteria: Neurologic disorder Psychiatric disorder Drug addiction Alcoholism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey Vanhaudenhuyse, PhD
Phone
+3243668482
Email
avanhaudenhuyse@chuliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Aminata Bicego, PhD Student
Phone
+3243663499
Email
abicego@uliege.be
Facility Information:
Facility Name
Hospital University of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Vanhaudenhuyse, PhD
Phone
+3243668482
Email
avanhaudenhuyse@chuliege.be
First Name & Middle Initial & Last Name & Degree
Aminata Bicego, PhD Student
Phone
+3243663499
Email
abicego@uliege.be

12. IPD Sharing Statement

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

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