Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in preoperative anxiety level the day before the surgery in study groups
研究概览
简要总结
The aim of the study is to investigate the effect of preoperative patient education on the level of properative anxiety and postoperative psychosocial outcomes. Participants will be assigned to one of the 3 study groups: on-line education, contact education and control (no preoperative education). The investigators will evaluate preoperative anxiety level at different time points (baseline at 2 weeks before the surgery, at the evening before the surgery and postoperatively) and investigate dynamics of anxiety in the perioperative period. Additional qualitative interview by psychologists will be performed to evaluate the potential causes of increased/decreased preoperative anxiety.
Impact on postoperative complications, well-being of the participant, quality of recovery and satisfaction with medical care will also be evaluated.
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
- Double (Care Provider, 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
- •agreement to participate in the study
- •elective cholecystectomy or colon surgery
排除标准
- •refusal to participate in the study
- •do not speak Lithuanian
- •do not pass the PHQ-2 depression screening test
结局指标
主要结局
Change in preoperative anxiety level the day before the surgery in study groups
时间窗: The day before the surgery
Preoperative anxiety level will be compared with the baseline anxiety level evaluated at 10-14 days before the surgery. Anxiety level will be evaluated using Depression, Anxiety and Stress Scale 21 (DASS-21). Each of 21 item in a scale is evaluated using Likert-type scoring system (0 to 3 points, where 0 - not present, 3 - very consistent). The higher the socre, the higher the level of anxiety (worse outcome)
Change in preoperative anxiety and information level the day before the surgery in study groups
时间窗: The day before the surgery
Preoperative anxiety level will be compared with the baseline anxiety level evaluated at 10-14 days before the surgery. Anxiety and information levels will be evaluated using Amsterdam Preoperative Anxiety and Information Scale (APAIS). Scale consists of 6 questions (4 regarding anxiety and 2 regarding information about surgery and anesthesia). Each question is scored by five point Likert-type scale (1 to 5, where 1 - not at all, 5 - extremely). The higher the score, the higher the anxiety and need for information about surgery and anesthesia (worse outcome).
次要结局
- Postoperative recovery(48 hours after discharge from the hospital)
- Postoperative well-being of the patient(First 3 days of the postoperative period)
- Postoperative pain levels(First 3 days of the postoperative period)
- Postoperative delirium(First 3 days of the postoperative period)
- Satisfaction with medical services(48 hours after discharge from the hospital)
研究者
Egle Kontrimaviciute
MD, PhD, Associate professor at Vilnius University, Lithuania
Vilnius University