The Impact of Psychological Support During the Hospitalization in Women With Endometriosis
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- General health state
研究概览
简要总结
Endometriosis is a common disease, causing significant pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically reducing patients' quality of life.
Endometriosis surgery is often a stressful event for the patient. For that reason, psychological support can improve patients' general health state.
详细描述
Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.
Psychological support is offered to all women one month before and one month after surgery. A group of patients will receive intensive psychological support during hospitalization.
Patients are divided into 2 groups:
Group A: patients receiving intensive psychological support during hospitalization
Group B: patients not receiving intensive psychological support during hospitalization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgery for endometriosis
- •Patients that have signed an informed consent
排除标准
- •Patients with active or history of psychological/psychiatric diseases
- •Patients that refuse psychological support
研究组 & 干预措施
Group A (intensive support)
Patients that receive standard and intensive psychological support during hospitalization
干预措施: Intensive psychological support (Procedure)
Group A (intensive support)
Patients that receive standard and intensive psychological support during hospitalization
干预措施: Standard psychological support (Procedure)
Group B (standard support)
Patients that receive only standard psychological support during hospitalization
干预措施: Standard psychological support (Procedure)
结局指标
主要结局
General health state
时间窗: From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
Measurement of quality of life of patients underwent surgery for endometriosis, using the validated questionnaire Clinical Outcomes In Routine Evaluation, with a total score from 1 (the best outcome) to more than 85 (the worse outcome), where: 1 to 20 is Healthy; 21 to 33 is Low level; 34 to 50 is Mild level; 51 to 67 is Moderate level; 68 to 84 is Moderate to severe level; more than 85 is Severe level. The questionnaire is submitted one month before surgery and at the hospitalization discharge.
次要结局
- Postoperative pain: Numeric Rating Scale(Postoperative: at the hospitalization discharge (assessed up to 7 days after surgery) and one month after surgery)
- Stress(From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery)
- Anxiety and Depression(From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery)
研究者
Renato Seracchioli
principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna