Self-induced Cognitive Trance for Chronic Pain Management

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038370
• Other study ID #: 2015-85
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: January 30, 2026

Study information

• Verified date: September 2023
• Source: University of Liege
• Contact: Aminata Aminata, PhD
• Email: abicego[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: January 30, 2026
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• French speacking
• Chronic pain
• On stable pharmacological treatment over the last four months

Exclusion Criteria:

• Psychiatric disorders,
• drug addiction
• alcoholism

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Self-induced cognitive trance
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.

Locations

Country	Name	City	State
Belgium	CHU of Liège	Liège
Belgium	University of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Experience with trance	Semi-structured interview	Immediately after the second workshop