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HYMACO is a monocentric, randomized comparative pilot study with a total duration of 25 months. The purpose of this study is to evaluate the effectiveness of autoHYpnosis by anchoring in the prevention of anxiety related to wearing the mask for radiotherapy of head and neck tumors.
60 patients will be randomized into 3 arms ARM A : Standard care ARM B : Autohypnosis ARM C : Musicotherapy This study is carried out during the first 5 radiotherapy sessions because this is decisive for the good progress of subsequent sessions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A : standard care | Active Comparator | standard care : Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care |
|
| ARM B : standard care + Autohypnosis | Active Comparator | In addition to the standard care, the patient will be called to learn autohypnosis during a specific consultation, with a radiotherapy manipulator trained to learn this technic. The patient will use this technic during the centering scanner and the first 5 radiotherapy sessions |
|
| ARM C : standard care + Musicotherapy | Active Comparator | In addition to the standard care, the patient will choose the music he want to listen from a music database (3 specific moods). The chosen music will be broadcast to the patient via a hi-fi system present in the treatment room during the centering scanner and for the first 5 radiotherapy sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Other | Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Anxiety will be assessed by the maximum value obtained on the STAI form Y-A questionnaire (state anxiety) on the following 3 measurements: on the centering scanner, at the first and 5th radiotherapy session. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Anxiety will also be assessed by a digital rating scale (0 to 10), in the centering or radiotherapy scanner room, just before making the mask before the centering scan and before fitting the mask before each of the first five radiotherapy sessions | 5 weeks |
| Conduct of radiotherapy session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rémi ETIENNE | Institut de Cancérologie de Lorraine | Study Chair |
| RENARD Sophie, MD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France | |||
| Institut de Cancérologie de Lorraine |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Autohypnosis | Other | The patient will be called to learn autohypnosis during a specific consultation, with a radiotherapy manipulator trained to learn this technic. The patient will use this technic during the centering scanner and the first 5 radiotherapy sessions |
|
| Musicotherapy | Other | the patient will choose the music he want to listen from a music database (3 specific moods). The chosen music will be broadcast to the patient via a hi-fi system present in the treatment room during the centering scanner and for the first 5 radiotherapy sessions |
|
The good conduct of the centering scanner and radiotherapy session is determined by:
|
| 5 weeks |
| Time required by the hypnopractor for the hypnosis session | The duration of the conditioning hypnosis session will be collected by the hypnopractor manipulator | 1 hour |
| Receptivity of patients to hypnosis | Corresponds to the time difference in minutes between the actual time of making and wearing the compression mask for the centering scanner and wearing a compression mask for the first 5 radiotherapy sessions and the time estimated by the patient | 5 weeks |
| Assessment of the patient's feelings | The patient's feelings will be evaluate a questionnaire composed of 5 questions already used in a previous study | 1 hour |
| Hypnopractic manipulator's satisfaction with the ease of performing the conditioning hypnosis | Assesing by the hypnopractor manipulator at the end of the session using a digital rating scale (0 to 10). | 1 hour |
| Vandœuvre-lès-Nancy |
| Vandoeuvre lès Nancy |
| France |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |