Chronic PainNCT06038370
Self-induced Cognitive Trance for Chronic Pain Management
A study testing Self-induced cognitive trance in people with Chronic Pain, run by University of Liege at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Self-induced cognitive trance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Jan 2023to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- French speacking
- Chronic pain
- On stable pharmacological treatment over the last four months
Who cannot join
- Psychiatric disorders,
- drug addiction
- alcoholism
Trial locations and contacts
2 sites in 1 country.
Aminata Aminata, PhD contact
Belgium2 sites, 2 recruiting
- Recruiting
CHU of Liège
Liège, 4000
Aminata Bicego, PhD, 003243663499, abicego@uliege.be
Audrey Vanhaudenhuyse, PI, 003243668033, avanhaudenhuyse@chuliege.be
- Recruiting
University of Liège
Liège, 4000
Audrey Vanhaudenhuyse, PhD, +3243668482, avanhaudenhuyse@chuliege.be
Aminata Bicego, PhD, +3243663499, abicego@uliege.be
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Being tested
- Self-induced cognitive trance
- Keywords
- Self-induced cognitive trance, Non-ordinary state of consciousness, Pain, Quality of life
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-induced cognitive tranceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-induced cognitive trance | Experimental | Not described Receives: Behavioral: Self-induced cognitive trance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: Immediately after the second workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start15 Jan 2023
- Primary completion10 Feb 2024 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrey Vanhaudenhuyse, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038370
- Sponsor's protocol ID
- 2015-85
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-induced Cognitive Trance to Improve Quality of Life of Patients With Chronic
- ClinicalTrials.gov ID
- NCT06038370
- Acronym / sponsor ID
- 2015-85
- Conditions
- Chronic Pain
- Keywords
- Self-induced cognitive trance, Non-ordinary state of consciousness, Pain, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 10 Feb 2024 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-induced cognitive trance | Experimental | Behavioral: Self-induced cognitive trance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- French speacking
- Chronic pain
- On stable pharmacological treatment over the last four months
Key exclusion criteria (3 listed)
- Psychiatric disorders,
- drug addiction
- alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-induced cognitive tranceThe 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. | Behavioural | Self-induced cognitive trance |
Primary outcome
Pain intensity
Time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
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
Time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
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
Time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
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
Time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
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
Time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
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
Time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
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
Time frame: 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 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.
6 secondary outcomes
Positive affect
Time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Negative affect
Time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Ego-Dissolution
Time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Mystical Experience
Time frame: 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
Time frame: 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
Time frame: Immediately after the second workshop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminata Aminata, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-induced cognitive trance in people with Chronic Pain, run by University of Liege at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aminata Aminata, PhD (abicego@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.