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

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Head and Neck Tumors

Treatments: Other: Autohypnosis; Other: Standard care; Other: Musicotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04671485

2020-A00813-36

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

ARM A : standard care

Active Comparator group

Description:

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

Treatment:

Other: Standard care

ARM B : standard care + Autohypnosis

Active Comparator group

Description:

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

Treatment:

Other: Standard care

Other: Autohypnosis

ARM C : standard care + Musicotherapy

Active Comparator group

Description:

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

Treatment:

Other: Musicotherapy

Other: Standard care