Self-induced Cognitive Trance for Chronic Pain Management

NCT06038370 | Unknown

• 1 other identifier: 2015-85
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain

Keywords

Self-induced cognitive trance; Non-ordinary state of consciousness; Pain; Quality of life

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Positive affect

  Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up

• Negative affect

  Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up

• Ego-Dissolution

  Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up

• Mystical Experience

  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 before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up

Study Arms (1)

Self-induced cognitive trance

EXPERIMENTAL

Behavioral: Self-induced cognitive trance

Interventions

Self-induced cognitive trance BEHAVIORAL

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.

Self-induced cognitive trance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Psychiatric disorders,
• drug addiction
• alcoholism

Sponsors & Collaborators

• University of Liege: lead

Study Sites (2)

CHU of Liège

Liège, 4000, Belgium

RECRUITING

University of Liège

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aminata Aminata, PhD

CONTACT

abicego@uliege.be

Vanhaudenhuyse Audrey, PhD

CONTACT

003243238033; avanhaudenhuyse@chuliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 14, 2023
• Study Start: January 15, 2023
• Primary Completion: February 10, 2024
• Study Completion: January 30, 2026
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

BE (2)