Effectiveness of autoHYpnosis in the Prevention of Anxiety During Radiotherapy of Head and Neck Tumors (HYMACO)
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: ARM A : standard care 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 |
Other: 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
|
| Active Comparator: ARM B : standard care + Autohypnosis 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 |
Other: 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
Other: Autohypnosis
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
|
| Active Comparator: ARM C : standard care + Musicotherapy 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 |
Other: 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
Other: Musicotherapy
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
|
Outcome Measures
Primary Outcome Measures
- Anxiety [5 weeks]
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.
Secondary Outcome Measures
- Anxiety [5 weeks]
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
- Conduct of radiotherapy session [5 weeks]
The good conduct of the centering scanner and radiotherapy session is determined by: no interruption of the session the absence of vocal intervention by the manipulator during the session
- Time required by the hypnopractor for the hypnosis session [1 hour]
The duration of the conditioning hypnosis session will be collected by the hypnopractor manipulator
- Receptivity of patients to hypnosis [5 weeks]
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
- Assessment of the patient's feelings [1 hour]
The patient's feelings will be evaluate a questionnaire composed of 5 questions already used in a previous study
- Hypnopractic manipulator's satisfaction with the ease of performing the conditioning hypnosis [1 hour]
Assesing by the hypnopractor manipulator at the end of the session using a digital rating scale (0 to 10).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age > or =18
-
Patient to receive radiotherapy for a tumor of the head and neck, with a compression mask
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Patient who obtained a score equal to or greater than 56 on the STAI form Y-A questionnaire during the consultation with the radiotherapist before starting treatment
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Patient capable and willing to follow all study procedures in accordance with the protocol
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Patient who understood the study and gave informed consent
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Patient affiliated to a social security system
Exclusion Criteria:
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Contraindication to hypnosis: psychosis, schizophrenia
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Non-French speaking patient
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Significant hearing loss
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Pregnant woman, likely to be, or breastfeeding
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Persons deprived of their liberty or under guardianship (including guardianship)
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Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons
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Patient who has already received radiotherapy to the head or neck with a compression mask
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut de Cancérologie de Lorraine | Vandoeuvre les nancy | France | 54519 | |
| 2 | Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | France | Vandoeuvre lès Nancy |
Sponsors and Collaborators
- Institut de Cancérologie de Lorraine
Investigators
- Study Chair: Rémi ETIENNE, Institut de Cancérologie de Lorraine
- Principal Investigator: RENARD Sophie, MD, Institut de Cancérologie de Lorraine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-A00813-36