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

Head and Neck Tumors Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04671485
• Other study ID #: 2020-A00813-36
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2020
• Est. completion date: January 2025

Study information

• Verified date: July 2023
• Source: Institut de Cancérologie de Lorraine
• Contact: Jean Louis MERLIN, PU PH
• Phone: +33 (0)3 83 65 60 62
• Email: jl.merlin[@]nancy.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head and Neck Tumors

Intervention

Other:
• 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
• Autohypnosis
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
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

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy
France	Institut de Cancérologie de Lorraine	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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