Back to results

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

Primary Purpose

Head and Neck Tumors

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Standard care

Autohypnosis

Musicotherapy

About this trial

This is an interventional supportive care trial for Head and Neck Tumors focused on measuring Autohypnosis, Anxiety, 5 points Mask, Radiotherapy, Anchoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institut de Cancérologie de Lorraine
Institut de Cancérologie de LorraineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

ARM A : standard care

ARM B : standard care + Autohypnosis

ARM C : standard care + Musicotherapy

Arm 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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Time required by the hypnopractor for the hypnosis session

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

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

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

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).

Full Information

NCT ID

NCT04671485

First Posted

December 7, 2020

Last Updated

July 27, 2023

Sponsor

Institut de Cancérologie de Lorraine

1. Study Identification

Unique Protocol Identification Number

NCT04671485

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 16, 2020 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut de Cancérologie de Lorraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Tumors

Keywords

Autohypnosis, Anxiety, 5 points Mask, Radiotherapy, Anchoring

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ARM A : standard care

Arm Type

Active Comparator

Arm 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

Arm Title

ARM B : standard care + Autohypnosis

Arm Type

Active Comparator

Arm Description

Arm Title

ARM C : standard care + Musicotherapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Standard care

Intervention Description

Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care

Intervention Type

Other

Intervention Name(s)

Autohypnosis

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Musicotherapy

Intervention Description

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 Outcome Measure Information:

Title

Anxiety

Description

Time Frame

5 weeks

Secondary Outcome Measure Information:

Title

Anxiety

Description

Time Frame

5 weeks

Title

Conduct of radiotherapy session

Description

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

Time Frame

5 weeks

Title

Time required by the hypnopractor for the hypnosis session

Description

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

Time Frame

1 hour

Title

Receptivity of patients to hypnosis

Description

Time Frame

5 weeks

Title

Assessment of the patient's feelings

Description

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

Time Frame

1 hour

Title

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

Description

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

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean Louis MERLIN, PU PH

Phone

+33 (0)3 83 65 60 62

jl.merlin@nancy.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Marie-Aude HERMAN

Phone

+33 (0)3 83 53 86 68

m.herman@nancy.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rémi ETIENNE

Organizational Affiliation

Institut de Cancérologie de Lorraine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

RENARD Sophie, MD

Organizational Affiliation

Institut de Cancérologie de Lorraine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Cancérologie de Lorraine

City

Vandoeuvre les nancy

ZIP/Postal Code

54519

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie RENARD, MD

Phone

+33 (0)3 83 59 85 34

s.renard@nancy.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Rémi ETIENNE

Phone

+33 (0)3 83 59 40 07

r.etienne@nancy.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Jean-Christophe Faivre, MD

First Name & Middle Initial & Last Name & Degree

Paul Jung, MD

First Name & Middle Initial & Last Name & Degree

Anaïs Stéfani, MD

First Name & Middle Initial & Last Name & Degree

Maria Jolnerovski, MD

Facility Name

Institut de Cancérologie de Lorraine

City

Vandœuvre-lès-Nancy

ZIP/Postal Code

Vandoeuvre lès Nancy

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie RENARD, MD

Phone

038359427

Ext

0033

s.renard@nancy.unicancer.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs