Clinical trial NCT06817837: Feasibility Study: The Contribution of Hypnosis in the Management of Adults With Brain Injuries
Official title: Feasibility Study: The Contribution of Hypnosis in the Management of Adults With Brain Injuries
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Traumatic Brain Injury
Keywords: hypnosis
stroke
traumatic brain injury
pain
sleep disorders
anxiety
behaviorals disorders
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An experimental group and a control group
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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;
* Stability of medication treatment during the month prior to inclusion.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Short Form Health Survey (SF 36)
timeFrame: At the inclusion of the patient and up to 8 weeks
Secondary outcomes:
measure: Visual Analogic Scales (VAS)
timeFrame: At the inclusion of the patient and up to 8 weeks.
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: At the inclusion of the patient and up to 8 weeks
measure: Questionnaire DysEXecutif (DEX) - Behavioural Assessment of the Dysexecutive Syndrome (BADS)
timeFrame: At the inclusion of the patient and up to 8 weeks
measure: Beck Depression Inventory, BDI
timeFrame: At the inclusion of the patient and at up to 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At the inclusion of the patient and up to 8 weeks
Other outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: At the inclusion of the patient
measure: Glasgow Coma Scale (GCS)
timeFrame: At the inclusion of patient
Locations:
city: Tinlot
country: Belgium
facility: CHU de Liège
state: Liège
Study officials:
References:
citation: 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.