The Influence of Therapeutic Listening on Anxiety and Fear Related to Surgery in Patients Preoperatively of Colorectal Surgery: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
This is a randomized clinical trial that aims to investigate the effect of therapeutic listening anxiety and preoperative fear of patients hospitalized for surgical treatment of colorectal cancer. Physiological variables will be evaluated (heart rate, blood pressure and respiratory rate), cortisol and salivary amylase and anxiety scores by State-Trait Anxiety Inventory and fear for Surgery Fear Questionnaire. The data of the variables will be compared at two different times (before and after the intervention).
详细描述
To calculate the sample size was chosen when using numerical scale IDATE. Considering that you want to detect a difference of 10 points (δ) in the range with a significance level of 5% (Z1-α = 1.96), a power of 80% (Z1-β = 1.96). The result obtained was 25 subjects for each group. Information related to variances of control and intervention groups were obtained through the pilot study and a correlation of 0.5 was assumed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •be 18 years of age;
- •be hospitalized for performing surgical oncology;
- •not be performing another treatment for cancer;
- •not be participating in another study;
- •be clinically well and / or stable (have score less than or equal to 3 by the Eastern Cooperative Oncology Group - Performance Status).
排除标准
- •being illiterate, a condition that will prevent the participant to answer the questionnaires and instruments of the study, which are self-administered;
- •be in possession of psychiatric disorders;
- •be using medication containing corticosteroids.
研究组 & 干预措施
Experimental Group
This group will receive the therapeutic listening.
干预措施: Therapeutic listening (Other)
Control Group
This group will receive usual care offered by the hospital where the study will be conducted.
结局指标
主要结局
State-Trait Anxiety Inventory (STAI)
时间窗: Patients will be followed on three occasions during the preoperative period, an average of 24 hours before surgery.
Change in STAI, a questionnaire to assess anxiety levels.
次要结局
- Salivary amylase(Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.)
- Surgical Fear Questionnaire (SFQ)(Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.)
- Respiratory rate(Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.)
- Salivary cortisol(Patients will be followed on four occasions during the preoperative period, an average of 24 hours before surgery.)
- Blood pressure(Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.)
- Heart rate(Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.)
研究者
Ana Cláudia Mesquita
Nurse - PhD Student
University of Sao Paulo