Effectiveness of autoHYpnosis in the Prevention of Anxiety During Radiotherapy of Head and Neck Tumors (HYMACO)

Study Overview
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Brief Summary
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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

Official Title
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Randomized, Comparative Pilot Study Evaluating the Effectiveness of autoHYpnosis by Anchoring in the Prevention of Anxiety Related to Wearing the Mask for Radiotherapy of Head and Neck Tumors

Conditions
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Head and Neck Tumors

Intervention / Treatment
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* Other: Standard care
* Other: Autohypnosis
* Other: Musicotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or =18 Patient to receive radiotherapy for a tumor of the head and neck, with a compression mask 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 Patient capable and willing to follow all study procedures in accordance with the protocol Patient who understood the study and gave informed consent Patient affiliated to a social security system Exclusion Criteria: Contraindication to hypnosis: psychosis, schizophrenia Non-French speaking patient Significant hearing loss Pregnant woman, likely to be, or breastfeeding Persons deprived of their liberty or under guardianship (including guardianship) Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons Patient who has already received radiotherapy to the head or neck with a compression mask

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARM A : standard care<br>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<br>* Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care<br>|
| Active Comparator: ARM B : standard care + Autohypnosis<br>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<br>* Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care<br>Other: Autohypnosis<br>* 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<br>|
| Active Comparator: ARM C : standard care + Musicotherapy<br>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<br>* Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care<br>Other: Musicotherapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anchoring, Autohypnosis, Anxiety, 5 points Mask, Radiotherapy