Effects of Pre-operative Speech-Language Pathology Counselling in Patients Undergoing to Total Laryngectomy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Impact of Event Scale-revised
研究概览
简要总结
The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP) counselling on patients undergoing total laryngectomy in terms of levels of distress, post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of the new voice.
This is a randomized controlled trial (RCT) of patients undergoing total laryngectomy and primary tracheoesophageal puncture. Patients will be randomized into two groups: an Experimental group that will receive a pre-operative SLP counselling session and a Control group that will not receive it. The investigators will administer a structured interview and three questionnaires: the Impact of Event Scale - Revised (IES-R), the Psychological Distress Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS). The data will be collected between the 5th and 7th day after surgery (T0), 1-month (T1) and 3-months (T2) after being discharged from hospital.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18 years and over;
- •patients waiting for TL and primary TEP;
- •patients able and willing to provide written informed consent.
排除标准
- •positive history for psychiatric or psychological disorders,
- •neurological disorders,
- •ineligibility for voice prosthesis rehabilitation.
结局指标
主要结局
Impact of Event Scale-revised
时间窗: three months after being discharged from hospital (T2)
presence of post-traumatic symptoms
次要结局
- Psychological Distress Inventory(three months after being discharged from hospital (T2))
- Hospital Anxiety and Depression Scale(three months after being discharged from hospital (T2))
研究者
LONGOBARDI YLENIA
researcher
Fondazione Policlinico Universitario Agostino Gemelli IRCCS