Self-induced Cognitive Trance for Chronic Pain Management

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Self-induced cognitive trance

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aminata Aminata, PhD; Email: abicego@uliege.be
• Study Contact Backup: Name: Vanhaudenhuyse Audrey, PhD; Phone Number: 003243238033; Email: avanhaudenhuyse@chuliege.be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • University of Liege
    • Contact: Aminata Bicego, PhD; Phone Number: +3243663499; Email: abicego@uliege.be
    • Contact: Audrey Vanhaudenhuyse, PhD; Phone Number: +3243668482; Email: avanhaudenhuyse@chuliege.be
    • Principal Investigator: Olivia Gosseries, PhD
  • Liège, Belgium, 4000
    • Recruiting
    • Chu of Liège
    • Contact: Aminata Bicego, PhD; Phone Number: 003243663499; Email: abicego@uliege.be
    • Contact: Audrey Vanhaudenhuyse, PI; Phone Number: 003243668033; Email: avanhaudenhuyse@chuliege.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Psychiatric disorders,
• drug addiction
• alcoholism

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Self-induced cognitive trance

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Estimated): February 10, 2024
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Quality of life; Self-induced cognitive trance; Non-ordinary state of consciousness
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2015-85

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No