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NCT Number: NCT04671485

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

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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Key information

Conditions

Head and Neck Tumors Anxiety Disorders Head and Neck Neoplasms Mental Disorders Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Anxiety

    Time frame: 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 outcomes

  1. Anxiety

    Time frame: 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

  2. Conduct of radiotherapy session

    Time frame: 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

  3. Time required by the hypnopractor for the hypnosis session

    Time frame: 1 hour

    The duration of the conditioning hypnosis session will be collected by the hypnopractor manipulator

  4. Receptivity of patients to hypnosis

    Time frame: 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

  5. Assessment of the patient's feelings

    Time frame: 1 hour

    The patient's feelings will be evaluate a questionnaire composed of 5 questions already used in a previous study

  6. Hypnopractic manipulator's satisfaction with the ease of performing the conditioning hypnosis

    Time frame: 1 hour

    Assesing by the hypnopractor manipulator at the end of the session using a digital rating scale (0 to 10).

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study 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

Acronym: HYMACO

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Dec 17, 2020
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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