Clinical trial NCT04671485: Effectiveness of AutoHYpnosis in the Prevention of Anxiety During Radiotherapy of Head and Neck Tumors (HYMACO)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Tumors
Keywords: Autohypnosis
Anxiety
5 points Mask
Radiotherapy
Anchoring
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: 5 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: 5 weeks
measure: Conduct of radiotherapy session
timeFrame: 5 weeks
measure: Time required by the hypnopractor for the hypnosis session
timeFrame: 1 hour
measure: Receptivity of patients to hypnosis
timeFrame: 5 weeks
measure: Assessment of the patient's feelings
timeFrame: 1 hour
measure: Hypnopractic manipulator's satisfaction with the ease of performing the conditioning hypnosis
timeFrame: 1 hour
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: Rémi ETIENNE
role: STUDY_CHAIR
affiliation: Institut de Cancérologie de Lorraine
name: RENARD Sophie, MD
role: PRINCIPAL_INVESTIGATOR
References: