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临床试验/NCT06419088
NCT06419088进行中(未招募)不适用

Effect of Preoperative Individualized Education on Anxiety and Recovery in Patients Undergoing Minimally Invasive Lung Surgery

Fujian Medical University Union Hospital1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
156
试验地点
1
主要终点
Sleep disorders

研究概览

简要总结

Researchers aim to investigate whether individualized preoperative education for patients is beneficial in reducing perioperative anxiety, promoting postoperative recovery, and enhancing postoperative quality of life. The educational content will cover aspects such as the surgery procedure, anesthesia, postoperative pain and anxiety management, recovery time, and any potential required treatments. All participants will be administered a questionnaire before the surgery to evaluate their specific concerns and fears. The intervention group will receive preoperative education through audio-visual materials followed by targeted preoperative counseling, while the control group will receive routine preoperative education.

详细描述

Patients who met the research criteria were consulted prior to surgery, during which the research objectives were explained, and written consent was obtained. Following baseline assessment, patients were randomly allocated to either the individualized education group or the routine education group. Sociodemographic information was collected through face-to-face interviews conducted in the ward. Additionally, levels of anxiety and adverse events (sleep, pain, nausea, vomiting) were measured using the Visual Analog Scale (VAS) and Hospital Anxiety and Depression Scale (HADS). Patient anxieties regarding different aspects were assessed using specific concerns and fears scales.

The intervention group received individualized educational interventions utilizing audiovisual materials. Based on identified personalized educational needs, researchers administered individualized preoperative education to the intervention group in the ward. Patients in the control group received only routine preoperative education from clinical nurses.

The second assessment was conducted before patients were transferred to the operating room. Anxiety levels and adverse events (preoperative sleep, pain, nausea, and vomiting) were assessed using HADS and VAS. Postoperatively, pain, nausea, vomiting, and coughing were evaluated three times daily for the first three days (every 8 hours) using the Visual Analog Scale (VAS), and sleep was assessed daily using the Athens Insomnia Scale (AIS). Chronic symptoms and quality of life were assessed at postoperative weeks 1, 2, 4, 12, 26, and 52. Chronic cough was evaluated using the Leicester Cough Questionnaire, and chronic pain was evaluated using the Brief Pain Inventory. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and HADS were used for continuous assessment of quality of life, anxiety, and depression status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 or above;
  • Received single-port thoracoscopic surgery;
  • Volunteered to participate in the study and signed an informed consent form.

排除标准

  • Presence of a mental disorder
  • Preoperative pain
  • Presence of other tumours requiring treatment.

结局指标

主要结局

Sleep disorders

时间窗: Baseline, postoperative days 1,2,3

Change in Athens Insomnia Scale

Postoperative pain

时间窗: Baseline, postoperative days 1,2,3

The Visual Analog Scale (VAS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.

Anxiety status

时间窗: Before and after education, 12 months after surgery

Change in anxiety intensity scores

Postoperative nausea and vomiting

时间窗: Baseline, postoperative days 1,2,3

The Visual Analog Scale (VAS) was used to evaluate the intensity of nausea and vomiting

次要结局

  • Postoperative Complications(12 months after surgery)
  • Quality of life after surgery(Baseline, 12 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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