Feasibility Study: The Contribution of Hypnosis in the Management of Adults With Brain Injuries

NCT06817837 | Enrolling By Invitation DMC

• 1 other identifier: 2024-446
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This controlled and randomized study aims to explore the feasibility and benefits of hypnosis in the management of patients who have suffered a traumatic brain injury or a stroke, by assessing its impact on behavioral disorders related to the dysexecutive syndrome, as well as associated symptoms (anxiety, sleep disorders, and pain). For this study, a convenience sample of 40 adult patients with acquired brain injuries will be recruited and randomly assigned to two groups: one group will receive hypnosis sessions integrated into their usual care, and the control group will receive only conventional treatment. These patients are currently being followed in neurological rehabilitation with complaints (anxiety, sleep, pain, and/or behavioral disorders). These complaints will be initially assessed using visual analog scales (VAS) for these four points. Patients with scores higher than 4 on at least two of the scales will be admitted to the study. They will be randomly assigned to either the control or experimental group. Sociodemographic data (age, sex, education) and certain medical data related to the brain injury will be collected, such as: the initial Glasgow Coma Scale score, medication treatment, lesion type, and the timing of the injury. Several questionnaires and scales will be completed at patient inclusion and at the end of the protocol. The severity of behavioral disorders will be assessed using the DysEXecutive (DEX) questionnaire from the Behavioral Assessment of the Dysexecutive Syndrome (BADS). For anxiety, pain, and/or sleep disorders, the following questionnaires will be used: the State-Trait Anxiety Inventory (STAI), the Beck Depression Inventory, the Pittsburgh Sleep Quality Index (PSQI), and the Medical Outcome Study Short Form (SF-36) for quality of life. For the hypnosis protocol (experimental group), 8 individual sessions will be offered to the patient, each lasting about one hour and spread over a period of 4 months (one hypnosis session every two weeks). The sessions will proceed as follows:

• In the first session, a history will be taken to gather the patient's request or issue for which they were referred for hypnosis, and specific goals will be established. An explanation of hypnosis will also be provided.
• The second session will offer a "safe haven" hypnosis, where the patient revisits a happy moment to find calm and a secure place.
• In the third session, a "red balloon" hypnosis will be offered, using a metaphor where the patient releases bothersome emotions.
• The fourth session will focus on sleep (hypnotic metaphor for sleep induction).
• The fifth session will use "object-tool" hypnosis, where the patient works on a specific issue represented metaphorically by an object and enhances it with tools that can modify it.
• The sixth session will introduce self-hypnosis training for the patient.
• The final two sessions will be personalized and address the patient's current needs. At the end of each session, patients will be asked to complete a visual analog scale (VAS) to measure their level of absorption in the hypnosis. Note that, except for the first two sessions, the order of the sessions may be slightly adjusted based on the patient's needs or requests. Patients in the control group will also complete the same questionnaires at inclusion and after 4 months. During the 4-month period, all patients, from both the hypnosis and control groups, will continue to receive multidisciplinary rehabilitation care. Furthermore, the hypnosis sessions will replace one neuropsychology session each time so that both groups (control vs. hypnosis) receive the same number of sessions over the period. Finally, data will be analyzed for patients who have completed at least 80% of the prescribed hypnosis sessions.

Conditions

Stroke; Traumatic Brain Injury

Keywords

hypnosis; stroke; traumatic brain injury; pain; sleep disorders; anxiety; behaviorals disorders

Outcome Measures

Primary Outcomes (1)

• Short Form Health Survey (SF 36)

  This is a self-reported questionnaire designed to assess health-related quality of life. It includes 36 items distributed across 8 dimensions: physical function, physical role limitations, bodily pain, general health, vitality, social function, emotional role limitations, and mental health. Each dimension is scored on a scale from 0 to 100, where 0 represents the worst health status and 100 the best. The SF-36 allows for the calculation of two overall scores: one for physical health and another for mental health.

  At the inclusion of the patient and up to 8 weeks

Secondary Outcomes (5)

• Visual Analogic Scales (VAS)

  At the inclusion of the patient and up to 8 weeks.

• State-Trait Anxiety Inventory (STAI)

  At the inclusion of the patient and up to 8 weeks

• Questionnaire DysEXecutif (DEX) - Behavioural Assessment of the Dysexecutive Syndrome (BADS)

  At the inclusion of the patient and up to 8 weeks

• Beck Depression Inventory, BDI

  At the inclusion of the patient and at up to 8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  At the inclusion of the patient and up to 8 weeks

Other Outcomes (2)

• Montreal Cognitive Assessment (MoCA)

  At the inclusion of the patient

• Glasgow Coma Scale (GCS)

  At the inclusion of patient

Study Arms (2)

hypnosis

EXPERIMENTAL

The patients in the experimental group will receive 8 hypnosis sessions, scheduled one session every two weeks. These will replace one neuropsychology session for the patient (patients will still be followed in neuropsychological rehabilitation). The procedure will therefore last 4 months. These hypnosis sessions aim to address anxiety, sleep disorders, pain, and/or behavioral disorders.

Behavioral: hypnosis

control

NO INTERVENTION

The patients in the control group will continue their usual multidisciplinary care without any changes.

Interventions

hypnosis BEHAVIORAL

Eight hypnosis sessions will be offered to address various issues: sleep disorders, behavioral issues, anxiety, and pain.

hypnosis

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years or older;
• Acquired brain injury of the type stroke (AVC) or traumatic brain injury (TBI), regardless of the severity;
• Presence of complaints of anxiety, sleep disorders, disabling pain, and/or behavioral disturbances;

You may not qualify if:

• Patients already receiving hypnosis treatment or practicing hypnosis. Patients with prior experience with hypnosis before the injury may be included;
• Patients presenting or who have presented with aphasia;
• Patients still experiencing post-traumatic confusion;
• Patients with a history of psychiatric disorders;
• History of alcoholism or drug addiction.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead

Study Sites (1)

CHU de Liège

Tinlot, Liège, 4557, Belgium

Location

Related Publications (1)

• Nagendra BD, Ramesh T, Meena M, Study of epidemiology of traumatic brain injury and prevalence of psychiatric disorders in traumatic brain injury at 3 months follow-up, 2019, Nepal Journal of Neurosciences 16 : 8-15.

  BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic; Pain; Sleep Wake Disorders; Anxiety Disorders

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: An experimental group and a control group

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 10, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)