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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ARM A : standard care
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
干预措施: Standard care (Other)
ARM B : standard care + Autohypnosis
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
干预措施: Standard care (Other)
ARM B : standard care + Autohypnosis
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
干预措施: Autohypnosis (Other)
ARM C : standard care + Musicotherapy
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
干预措施: Standard care (Other)
ARM C : standard care + Musicotherapy
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
干预措施: Musicotherapy (Other)
结局指标
主要结局
Anxiety
时间窗: 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.
次要结局
- Anxiety(5 weeks)
- Conduct of radiotherapy session(5 weeks)
- Time required by the hypnopractor for the hypnosis session(1 hour)
- Receptivity of patients to hypnosis(5 weeks)
- Assessment of the patient's feelings(1 hour)
- Hypnopractic manipulator's satisfaction with the ease of performing the conditioning hypnosis(1 hour)