Cognitive Trance, Hypnosis and Meditation in Oncology

Not Applicable

Active, not recruiting

• Conditions: Cancer; Pain; Fatigue; Sleep Disturbance; Distress, Emotional; Cognitive Impairment
• Interventions: Behavioral: Hypnosis group intervention; Behavioral: Meditation group intervention; Behavioral: Cognitive trance group intervention

• Registration Number: NCT04873661
• Lead Sponsor: University of Liege

Brief Summary

Patients with cancer often suffer from a symptom cluster, including pain, fatigue, sleep difficulties, emotional distress and cognitive impairments. In oncology settings, there is a growing interest in "mind-body" intervention, to relieve them in a non-pharmacological way. Hypnosis and meditation are two modified state of consciousness shown to positively this symptom cluster. Cognitive trance is also a modified state of consciousness, but is induced by body movements and/or vocalizations. Subjective reports of experts in cognitive trance showed a modification of self, emotion regulation, pain perception, attention and concentration. However, we still need to develop studies to better characterise this particular state of consciousness and its clinical applications. Our randomized-controlled trial aims at comparing both interventions in terms of (1) benefits on cancer patients' quality of life (pain, fatigue, sleep, distress, cognitive impairments), (2) phenomenological/subjective experiences and neurophysiological correlates, and (3) mechanisms involved in patients' responsiveness, based on the biopsychosocial model of hypnosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• ≥18 years old
• No neurological/psychiatric disorders/history of alcohol or drug abuse
• No current and regular practice of hypnosis, meditation or cognitive trance
• Diagnosis of cancer (all localisations accepted except brain tumours to avoid any effect on EEG data and cognitive impairments)
• Active treatments (surgery, chemotherapy, radiotherapy) finished for less than a year.
• Score of at least 4/10 for one of these four symptoms at baseline: pain, fatigue, sleep difficulties, emotional distress.

Exclusion Criteria

• < 18 year old
• No cancer diagnosis
• Neurological or psychiatric disorder
• Brain tumour ou other tumour with brain metastases
• Active treatments still ongoing or finished for more than a year
• No baseline symptom at 4/10

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis	Hypnosis group intervention	In the hypnosis-based intervention, patients (in groups of approximately 10 participants) will participate in 8 weekly sessions (2 hours each) during which they will benefit from guided hypnosis exercises, and learn how to implement self-hypnosis. They will also receive a CD with hypnosis exercises for home practice. At-home practice is encouraged between sessions.
Meditation	Meditation group intervention	The meditation-based intervention will consist of 8 weekly sessions (2h45 each) in groups of approximately 10 participants, as well as half a day of intensive practice between the fifth and the sixth session. Participants will learn how to implement self-compassion meditation, through practical exercises proposed during the sessions. At-home practice is encouraged between sessions.
Cognitive trance	Cognitive trance group intervention	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 Measures

Name	Time	Method
Change in Emotional distress	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire (Hospital Anxiety and Depression Scale; HADS). Score range from 0 to 42, with a higher score indicating higher emotional distress
Change in Fatigue	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire (Multidimensional Fatigue Inventory; MFI-20)
Change in Pain	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a visual analogue scale (VAS) (score range from 0 to 10/10, a higher score indicating a higher pain)
Change in Sleep difficulties	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire (Insomnia Severity Index; ISI). Score range from 0 to 28, with a higher score indicating higher sleep difficulties.
Change in Perceived cognitive difficulties	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire (FACT-Cog), investigation 4 dimensions (perceived cognitive impairments, score range 0-72, higher score indicating less impairments ; impact of cognitive impairments on quality of life, score range 0-16, with higher scoe indicating less impact ; Comments from others, score range 0-16 with higher score indicating less comments ; perceived cognitive abilities, score range 0-28, with higher score indicating more cognitive abilities)

Secondary Outcome Measures

Name	Time	Method
Fantasy Proneness (imaginative experiences)	Assessed before the intervention (T0)	Assessed with a questionnaire designed by our team investigating the previous imaginative experiences of the participant. 25 true/false items. Total score ranging from 0 to 25, with higher score indicating higher level of fantasy proneness.
Change in Empowerment	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire composed of 7 VAS (score from 0 to 10/10, with higher score indicating higher empowerment), based on the Health Education Impact Questionnaire (heiQ)
Change in Characteristics of the intense memory described above	Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire (Memory Characteristics Questionnaire; MCQ). Score range from 8 to 104, with higher score indicating higher degree of details about the memory.
Change in body movements	Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.	During the EEG, body movements will be measured (with an electromyogram).
Change in Psychological flexibility	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire (Multidimensional Psychological Flexibility Inventory; MPFI-24). Score range from 0 to 6 for each dimension (psychological flexibility and psychological inflexibility), with higher score indicating higher flexibility or inflexibility according to the dimension assessed.
Personnality characteristics	Assessed before the intervention (T0)	Assessed with a questionnaire (Big Five Short Form; BFI-10). 5 scales (extraversion, agreeableness, conscientiousness, neuroticism, openness to experience) with score range 1-5, with higher score indicating a stronger presence of this personality trait.
Expectations and motivation to participate in the chosen intervention	Assessed before the intervention (T0)	Assessed with 2 VAS (score range from 0 to 10/10, with higher score indicating higher motivation and higher expectations)
Change in the characteristics of a free recall of an intense hypnosis/cognitive trance/meditation episode (or an intense autobiographical episode for the participants in the control group)	Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Free text written by the participant
Change in presence during the intense memory described above	Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire designed by our team to assess the feeling of presence in the imaginative environment linked to the intense memory reported (hypnosis, trance, meditation or personal memory). 2 scales (Presence in the suggested environment and Interaction with others, score range for each dimension 6-42, with higher score indicating higer presence/interaction).
Change in the quality of the relationship with the therapist who animated the group sessions	Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a VAS (score range from 0 to 10/10, with higher score indicating better relationship quality).
Change in Emotion regulation	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire (Cognitive Emotion Regulation Questionnaire; CERQ). 2 summary scores (adpative regulation, score ranging from 20 to 100, with higher score indicating higher adaptive regulation ; non-adaptive regulation, score ranging 12-60, with higher score indicating higher non-adaptive regulation)
Change in Mystical characteristics of the intense memory described above	Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire (Revised Mystical Characteristics Questionnaire; MEQ-30). 4 scales (mystical, score range 0-75, with higher score indicating a more mystical experience ; Positive mood, score range 0-30, with higher score indicating more positive mood during the episode ; Transcendence of time and space, score range 0-30, with higher score indicating stronger trenscendence ; Ineffability, score range 0-15, with higher score indicating higher ineffability)
Change in Mental Adjustment to Cancer	Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)	Assessed with a questionnaire (Mental adjustment to cancer; MAC). 2 summary scores (Summary positive adjustment, score range from 17 to 68, with higher score indicating higher positive adjustmen ; Summary Negative Adjustment, score ranging from 16 to 64, with higher score indicating highr negative adjustment)
Personal definition of hypnosis/cognitive trance/meditation	Assessed before the intervention (T0)	Free text written by the participant
Change in body temperature	Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.	During the EEG, body temperature will be measured (with a dedicated electrode put on the chest).
Change in cerebral activity	Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.	Assessed with an electroencephalogram (EEG), during resting state and during hypnosis, trance or meditation, according to the chosen intervention. During the EEG, we will also measure the heart rate (with an electrocardiogram), the body temperature, the body movements (with an electromyogram) and the respiration amplitude.
Change in heart rate	Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.	During the EEG, heart rate will be measured (with an electrocardiogram).
Change in respiration	Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.	During the EEG, respiration (amplitude, effort) will be measured (with a dedicated belts put on the torso)

Trial Locations

Locations (1)

University of Liège; 🇧🇪 Liège, Belgium