Self-induced Cognitive Trance for Chronic Pain Management

Study Overview
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Brief Summary
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The need to find complementary approaches, based on a holistic perspective of the human being, takes on its full meaning in a political context that recommends efficient health programs. Self-induced cognitive trance is one of these complementary approaches, which induce a non-ordinary state of consciousness. The aim of this work is to evaluate whether learning self-induced cognitive trance can improve the quality of life of people with chronic pain. Participants will participate in two times two days workshop aiming at learning how to self-induce cognitive trance. Pain, Fatigue, anxiety, depression, attitudes towards pain, and quality of life will be assessed before and after each workshops. Two follow-ups at 6 and 12 months afer the last workshop will be caried out were outomes will be assessed. Furthmore, questionnaires related to the phenomenology of self-induced cognitive trance will be adeministrered. Investigators also proceeded to interveiwes after the second workshop to gather qualitative information.

Official Title
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Self-induced Cognitive Trance to Improve Quality of Life of Patients With Chronic

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Self-induced cognitive trance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: French speacking Chronic pain On stable pharmacological treatment over the last four months Exclusion Criteria: Psychiatric disorders, drug addiction alcoholism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-induced cognitive trance<br> | Behavioral: Self-induced cognitive trance<br>* The cognitive trance-based intervention will consist of a two-day workshop in groups of approximately 10 participants, where they will learn how to induce the cognitive trance, with the use of different sound-loops that can induce trance in untrained people in a safe way. After two weeks of home practice, participants will redo a two-day consolidation training. At-home practice is encouraged between sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Visual Analog Scale will be used to assess pain, at the present moment, at its weakest and strongest, on a scale of 0 (no pain) to 10 (worst pain imaginable) | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Fatigue intensity | Visual Analog Scale will be used to assess pain, at the present moment, at its weakest and strongest, on a scale of 0 (no pain) to 10 (worst pain imaginable) | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Anxiety | Hospital Anxiety and Depression scale comprises 14 items subdivided into 7 sub-items, each linked to a subscale, one for the level of anxiety and one for the level of depression, for a total score ranging from 0 to 21 for each of these subscales. A score of 0 to 7 is equivalent to a normal state, a score of 8 to 10 suggests only the presence of a mood disorder, a score of 11 to 15 indicates the probable presence of a moderate mood disorder, and finally, a score above 16 indicates a severe mood disorder. | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Depression | Hospital Anxiety and Depression scale comprises 14 items subdivided into 7 sub-items, each linked to a subscale, one for the level of anxiety and one for the level of depression, for a total score ranging from 0 to 21 for each of these subscales. A score of 0 to 7 is equivalent to a normal state, a score of 8 to 10 suggests only the presence of a mood disorder, a score of 11 to 15 indicates the probable presence of a moderate mood disorder, and finally, a score above 16 indicates a severe mood disorder. | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Attitudes towards pain | The Survey of Pain Attitude-35. It is composed of 7 subscales: perceived disability measures the belief that disability is caused by pain; pain-injury link assesses the belief that pain is a physical injury; medication measures the belief that medication is the only remedy, solicitude measures the belief that those around patients should assist them in their painful experience, expectation of cure measures the belief that doctors are responsible for reducing their pain, perceived control assesses the feeling of perceived control, and finally, emotion measures the feeling that emotions have an impact on pain. Scores are specific to each scale. The higher the score, the more patients hold this belief. | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Quality of life | The Short From Health Survey assesses overall quality of life. It comprises 36 items subdivided into 9 subscales: physical functioning, limitations resulting from physical health, limitations resulting from emotional health, vitality (energy/fatigue), emotional well-being, social functioning, pain, general state of health and, finally, changes in state of health. Each of these scales is weighted by a score ranging from 0 to 100. The first 8 dimensions of the SF-36 are grouped into 2 synthetic scores. A physical score (PCS) groups the 8 dimensions according to a weighting that favors the physical component, while the mental score (MCS) summarizes the mental component of the dimension scores. The higher the scores, the better the mental and physical health. The final item assesses perceived change in health status. | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Global Impression of change | Global Impression of change assesses patients' beliefs about the effectiveness of their treatment on their disease. It's a simple scale that goes up to 7 points, equivalent to the best possible improvement. | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive affect | The Positive Affect and Negative Affect Schedule is dedicated to measuring mood and feelings. The questionnaire comprises two scales. The first measures positive affect, the second negative affect. Each scale comprises 10 items, for a total of 20 items, and each item is rated on a scale from 1 (very little or not at all) to 5 (very much or not at all). | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Negative affect | The Positive Affect and Negative Affect Schedule is dedicated to measuring mood and feelings. The questionnaire comprises two scales. The first measures positive affect, the second negative affect. Each scale comprises 10 items, for a total of 20 items, and each item is rated on a scale from 1 (very little or not at all) to 5 (very much or not at all). | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Ego-Dissolution | Ego-Dissolution Inventory comprises 16 items subdivided into 2 subscales representing ego inflation and ego dissolution, each scale comprising 8 items. Each item is monitored by a numerical score ranging from 0 (no, no more than usual) to 100 (yes, entirely or completely). | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Mystical Experience | Mystical Experiences Questionnaire comprises 30 items divided into 4 subscales representing mysticism, which qualifies experiences of communication with a reality that cannot be discerned by common sense, positive mood, transcendence of time and space, and ineffability, which represents the experience of being able to communicate with a reality that cannot be discerned by common sense. considers that the experience cannot be described in words, each item is evaluated with a score ranging from 0 (none, not at all) to 5 (extreme, more than any other moment in my life and more than 4). | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Phenomenology of trance | Assessed through a self-made questionnaire. It consists of 10 questions, each of which is evaluated by a score ranging from 1 (strongly disagree) to 7 (strongly agree). | Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up | 
| Experience with trance | Semi-structured interview | Immediately after the second workshop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-induced cognitive trance, Non-ordinary state of consciousness, Pain, Quality of life