StrokeNCT06817837
Feasibility Study: The Contribution of Hypnosis in the Management of Adults With Brain Injuries
A study testing hypnosis in people with Stroke and Traumatic Brain Injury, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Traumatic Brain Injury
- What is being tested?
- hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Feb 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- hypnosis
- Keywords
- hypnosis, stroke, traumatic brain injury, pain, sleep disorders, anxiety, behaviorals disorders
- Medical subject headings
- Stroke, Brain Injuries, Traumatic, Pain, Sleep Wake Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisBehavioural
Eight hypnosis sessions will be offered to address various issues: sleep disorders, behavioral issues, anxiety, and pain.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: hypnosis |
| control | No intervention | The patients in the control group will continue their usual multidisciplinary care without any changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the inclusion of the patient and up to 8 weeks
Secondary outcomes (5)
Visual Analogic Scales (VAS)
This scale consists of a 10 cm horizontal line, marked at both ends with descriptors such as "not at all" (0) to "completely" (10). Participants are asked to rate their feelings from 0 to 10 regarding four symptoms: "I feel anxious," "I have sleep disturbances," "I have disabling pain," and "I exhibit behavioral disturbances."
Measured: At the inclusion of the patient and up to 8 weeks.
State-Trait Anxiety Inventory (STAI)
Anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI). The STAI is a psychometric tool that measures two aspects of anxiety: state anxiety (temporary anxiety related to a specific situation) and trait anxiety (stable, dispositional anxiety). It consists of two subscales, each with 20 items, rated from 1 (not at all) to 4 (very much). The total score for each subscale ranges from 20 to 80, with higher scores indicating higher levels of anxiety.
Measured: At the inclusion of the patient and up to 8 weeks
Questionnaire DysEXecutif (DEX) - Behavioural Assessment of the Dysexecutive Syndrome (BADS)
The severity of behavioral disorders will be assessed using the DEX questionnaire from the Behavioural Assessment of the Dysexecutive Syndrome (BADS). This questionnaire was developed to evaluate executive dysfunction in daily life activities. It is a self-assessment measure consisting of 20 items that assess four dysexecutive criteria: behavioral, cognitive, motivational, and emotional changes, compared to premorbid functioning. Each item is rated on a 5-point Likert scale ranging from "never" to "very often." The sum of each item provides an overall score from 0 to 80. The higher the score, the more severe the executive disorders are. This questionnaire has the advantage of providing both a self-assessment from the patient and an external assessment by the patient's referring neuropsychologist.
Measured: At the inclusion of the patient and up to 8 weeks
Beck Depression Inventory, BDI
This questionnaire is a self-reported tool consisting of 21 items, each rated from 0 to 3, assessing various symptoms of depression such as mood, cognition, sleep, and appetite. The total score ranges from 0 to 63, with thresholds indicating the severity of depression: 0-13 (minimal depression), 14-19 (mild), 20-28 (moderate), and 29-63 (severe). The scale is commonly used in both clinical practice and research to track the progression of depressive symptoms and measure the effectiveness of treatments.
Measured: At the inclusion of the patient and at up to 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
This self-reported questionnaire is designed to assess sleep quality and its impact on health over a 1-month period. It measures 7 components of sleep: subjective quality, sleep onset latency, sleep duration, usual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is rated from 0 to 3, with a total score ranging from 0 to 21. A score higher than 5 indicates poor sleep quality.
Measured: At the inclusion of the patient and up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start5 Feb 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An experimental group and a control group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Cassol, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817837
- Sponsor's protocol ID
- 2024-446
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: The Contribution of Hypnosis in the Management of Adults With Brain Injuries
- ClinicalTrials.gov ID
- NCT06817837
- Acronym / sponsor ID
- 2024-446
- Conditions
- Stroke, Traumatic Brain Injury
- Keywords
- hypnosis, stroke, traumatic brain injury, pain, sleep disorders, anxiety, behaviorals disorders
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 5 Feb 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Feb 2025 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An experimental group and a control group
| Arm | Type | Receives |
|---|---|---|
| hypnosis | Experimental | Behavioral: hypnosisThe 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. |
| control | No intervention | –The patients in the control group will continue their usual multidisciplinary care without any changes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| hypnosisEight hypnosis sessions will be offered to address various issues: sleep disorders, behavioral issues, anxiety, and pain. | Behavioural | hypnosis |
Primary outcome
Short Form Health Survey (SF 36)
Time frame: At the inclusion of the patient and up to 8 weeks
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.
5 secondary outcomes
Visual Analogic Scales (VAS)
Time frame: At the inclusion of the patient and up to 8 weeks.
State-Trait Anxiety Inventory (STAI)
Time frame: At the inclusion of the patient and up to 8 weeks
Questionnaire DysEXecutif (DEX) - Behavioural Assessment of the Dysexecutive Syndrome (BADS)
Time frame: At the inclusion of the patient and up to 8 weeks
Beck Depression Inventory, BDI
Time frame: At the inclusion of the patient and at up to 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At the inclusion of the patient and up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- BackgroundNagendra 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnosis in people with Stroke and Traumatic Brain Injury, run by Centre Hospitalier Universitaire de Liege at 1 site 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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Health Survey (SF 36) (time frame: At the inclusion of the patient and up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06817837, which also lists 1 linked publication.
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 10 Feb 2025.