Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- The Main Objective is to Compare the Level of Anxiety in the Experimental Arm With the Control Arm at 6 Months.
研究概览
简要总结
Patients with brain tumours experience a loss of independence, which may occur suddenly or gradually. Communication with the patient may be rapidly impaired, due to impaired alertness, language and/or neurocognitive disorders.
In addition to these clinical symptoms, there is a high level of anxiety and depression in this population due to the severity of the diagnosis, with a major impact on the patients' quality of life. In this study, we are mainly interested in the proportion of this population with communication disorders where speech therapy is important In order to better take into account anxiety, which is often difficult to verbalise due to communication problems, sophrology can be proposed as an alternative to psychological support, which is often too complicated or inappropriate.
After having noted positive feedback from patients after joint speech therapy and sophrology treatment, we wish to evaluate the interest of coupling sophrology treatment for patients with glial tumours requiring speech therapy.
Our hypothesis is that this association would improve the level of anxiety, the quality of life and have a positive impact on the patient's speech therapy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven grade III and IV glial tumours requiring speech therapy;
- •Patient willing to start outpatient speech therapy;
- •Patient aged 18 years and over;
- •Informed patient who has signed consent;
- •Patient affiliated to a social security scheme.
排除标准
- •Patient who has already had an initiation to sophrology in the context of his pathology;
- •Performance Status ≥ 4 ;
- •Patients suffering from psychiatric disorders; delusional phases, schizophrenia against the practice of sophrology;
- •Patient unable to follow the protocol (filling in questionnaires, attendance of sophrology and/or speech therapy sessions) for geographical, social or psychological reasons;
- •Patients who do not speak French;
- •Persons deprived of their liberty, under court protection, under curators or under the authority of a guardian.
- •Women who are pregnant, likely to be pregnant or breastfeeding;
研究组 & 干预措施
Experimental arm : Speech therapy + Sophrology
In the experimental arm, patients will receive 6 sessions of sophrology. The sessions are individual and last approximately 50 minutes.
In addition to the sophrology sessions, patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.
干预措施: Sophrology (Behavioral)
Experimental arm : Speech therapy + Sophrology
In the experimental arm, patients will receive 6 sessions of sophrology. The sessions are individual and last approximately 50 minutes.
In addition to the sophrology sessions, patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.
干预措施: Speech therapy (Behavioral)
Control arm : Speech therapy
Patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.
干预措施: Speech therapy (Behavioral)
结局指标
主要结局
The Main Objective is to Compare the Level of Anxiety in the Experimental Arm With the Control Arm at 6 Months.
时间窗: 6 months
Anxiety levels will be measured using the Hospital Anxiety and Depression Scale at 6 months in both treatment arms. The quality of life scale consists of 14 items scored from 0 to 3. A score of 0 indicates that the patient has no anxiety disorder, a score of 21 indicates that the patient has a severe anxiety disorder.
次要结局
- The Secondary Objective is to Evaluate the Impact of the Practice of Sophrology on the Patient's Quality of Life(6 months)