Head and Neck TumorsHYMACONCT04671485
Effectiveness of autoHYpnosis in the Prevention of Anxiety During Radiotherapy of Head and Neck Tumors (HYMACO)
A study testing Autohypnosis and Musicotherapy in people with Head and Neck Tumors, run by Institut de Cancérologie de Lorraine at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Tumors
- What is being tested?
- Autohypnosis and Musicotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Dec 2020to 5 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Vandoeuvre lès Nancy
About this study
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
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
- Conditions
- Head and Neck Tumors
- Being tested
- Standard care, Autohypnosis, Musicotherapy
- Keywords
- Autohypnosis, Anxiety, 5 points Mask, Radiotherapy, Anchoring
- Medical subject headings
- Head and Neck Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care
AutohypnosisOther
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
MusicotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| ARM A : standard care | Active comparator | 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 Receives: Other: Standard care |
| ARM B : standard care + Autohypnosis | Active comparator | 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 Receives: Other: Standard care; Other: Autohypnosis |
| ARM C : standard care + Musicotherapy | Active comparator | 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 Receives: Other: Standard care; Other: Musicotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start16 Dec 2020
- Primary completion11 Dec 2024
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rémi ETIENNE, Study chair, Institut de Cancérologie de LorraineRENARD Sophie, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671485
- Sponsor's protocol ID
- 2020-A00813-36
- Acronym
- HYMACO
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2020
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04671485
- Acronym / sponsor ID
- HYMACO / 2020-A00813-36
- Conditions
- Head and Neck Tumors
- Keywords
- Autohypnosis, Anxiety, 5 points Mask, Radiotherapy, Anchoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM A : standard care | Active comparator | Other: Standard carestandard 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 |
| ARM B : standard care + Autohypnosis | Active comparator | Other: Standard care, Other: AutohypnosisIn 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 |
| ARM C : standard care + Musicotherapy | Active comparator | Other: Standard care, Other: MusicotherapyIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard carePatient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care | Other | ARM A : standard care, ARM B : standard care + Autohypnosis, ARM C : standard care + Musicotherapy |
| AutohypnosisThe 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 | ARM B : standard care + Autohypnosis |
| Musicotherapythe 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 | ARM C : standard care + Musicotherapy |
Primary outcome
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.
6 secondary outcomes
Anxiety
Time frame: 5 weeks
Conduct of radiotherapy session
Time frame: 5 weeks
Time required by the hypnopractor for the hypnosis session
Time frame: 1 hour
Receptivity of patients to hypnosis
Time frame: 5 weeks
Assessment of the patient's feelings
Time frame: 1 hour
Hypnopractic manipulator's satisfaction with the ease of performing the conditioning hypnosis
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémi ETIENNE study chair
Institut de Cancérologie de Lorraine
RENARD Sophie, MD principal investigator
Institut de Cancérologie de Lorraine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autohypnosis and Musicotherapy in people with Head and Neck Tumors, run by Institut de Cancérologie de Lorraine at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.