Self-induced Cognitive Trance for Chronic Pain Management
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Self-induced cognitive trance
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Self-induced cognitive trance, Non-ordinary state of consciousness, Pain, Quality of life
Eligibility Criteria
Inclusion Criteria: French speacking Chronic pain On stable pharmacological treatment over the last four months Exclusion Criteria: Psychiatric disorders, drug addiction alcoholism
Sites / Locations
- CHU of LiègeRecruiting
- University of LiègeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Self-induced cognitive trance
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
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.
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.
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.
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.
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.
Secondary Outcome Measures
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).
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).
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).
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).
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).
Experience with trance
Semi-structured interview
Full Information
NCT ID
NCT06038370
First Posted
August 29, 2023
Last Updated
September 12, 2023
Sponsor
University of Liege
1. Study Identification
Unique Protocol Identification Number
NCT06038370
Brief Title
Self-induced Cognitive Trance for Chronic Pain Management
Official Title
Self-induced Cognitive Trance to Improve Quality of Life of Patients With Chronic
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
February 10, 2024 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Self-induced cognitive trance, Non-ordinary state of consciousness, Pain, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-induced cognitive trance
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Self-induced cognitive trance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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)
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Fatigue intensity
Description
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)
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Anxiety
Description
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.
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Depression
Description
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.
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Attitudes towards pain
Description
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.
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Quality of life
Description
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.
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Global Impression of change
Description
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.
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Secondary Outcome Measure Information:
Title
Positive affect
Description
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).
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Negative affect
Description
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).
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Ego-Dissolution
Description
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).
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Mystical Experience
Description
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).
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Phenomenology of trance
Description
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).
Time Frame
Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Title
Experience with trance
Description
Semi-structured interview
Time Frame
Immediately after the second workshop
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
French speacking
Chronic pain
On stable pharmacological treatment over the last four months
Exclusion Criteria:
Psychiatric disorders,
drug addiction
alcoholism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aminata Aminata, PhD
Email
abicego@uliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Vanhaudenhuyse Audrey, PhD
Phone
003243238033
Email
avanhaudenhuyse@chuliege.be
Facility Information:
Facility Name
CHU of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aminata Bicego, PhD
Phone
003243663499
Email
abicego@uliege.be
First Name & Middle Initial & Last Name & Degree
Audrey Vanhaudenhuyse, PI
Phone
003243668033
Email
avanhaudenhuyse@chuliege.be
Facility Name
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
Phone
+3243663499
Email
abicego@uliege.be
First Name & Middle Initial & Last Name & Degree
Olivia Gosseries, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Self-induced Cognitive Trance for Chronic Pain Management
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