A Study on the Effectiveness of WeChat-based Online Education to Reduce Perioperative Anxiety in Breast Cancer Patients: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- the incidence of preoperative anxiety
研究概览
简要总结
Patients who meet the enrollment criteria will be randomly assigned to the WeChat education group and the regular group. In addition to the regular preoperative visits, the WeChat education group will also watch science videos through WeChat before the surgical procedures. The regular group only received regular preoperative visits and education by ward nurses. The main observation indicator is the incidence of preoperative anxiety defined as the scores of State Anxiety Inventory more than 40 points.
详细描述
Patients who meet the inclusion criteria will be randomly assigned to the WeChat online education group or the regular group. Two researchers will conduct preoperative education, preoperative evaluation and postoperative follow-up respectively.The patients in WeChat group will be first assessed by a researcher on admission about anxiety and sleep (base on the State-Trait Anxiety Inventory (STAI) scale and the sleep quality scale (SQS)). Once the assessment completed, the patients are required to follow the WeChat public platform to watch the education videos when they are free. The content of the videos is jointly decided by the breast surgeon, anesthetists, and ward nurse including the overall prognosis, surgical approach, postoperative rehabilitation exercises, preparation for anesthesia, anesthesia approach and possible effects of anesthesia, which covers all aspects of surgery, anesthesia, and perioperative care. The videos are presented in an easy-to-understand pattern to ensure participants of all ages and levels of education comfortably understand the content. Participants can simply click on the video dialogue box in the public platform for playback and watch it unconditionally.Patients in regular group will be also assessed by the same researcher on admission for anxiety and sleep (base on State-Trait Anxiety Inventory (STAI) scale; sleep quality scale (SQS) scale). Upon completion of the assessment, they received oral instruction from the ward nurse covering the same contents as above instead of the education video.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants, the anesthesiologist, data collectors, the physicians performing the follow-up, and data analysts will be blinded to the group allocation. Blinding will maintain until the completion of the final analyses.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients scheduled for elective breast cancer resection;
- •aged 18 to 80 years,;
- •American Society of Anesthesiologists (ASA) physical status I-III.
排除标准
- •patients diagnosed with primary breast cancer combined with malignant tumors of other organs (such as lung, kidney, intestine, etc.);
- •patients with tumor recurrence after reoperation;
- •patients failing to cooperate with the study for any reason, such as communication disorders.
结局指标
主要结局
the incidence of preoperative anxiety
时间窗: The day before surgery
The primary outcome indicator is the incidence of preoperative anxiety, defined as a S-AI(The State Anxiety Inventory)score of \>40.The total S-AI score ranges from 20 to 80, with higher scores indicating more severe anxiety.When S-AI score exceeds 40, a state of clinical anxiety is confirmed25,26.A S-AI score outstripping 44 strongly denotes severe anxiety.
次要结局
- incidence of severe anxiety (S-AI > 44) on 1day before and at 72 hours after surgery(The day before and at 72 hours after surgery)
- incidence of anxiety 72 hours after surgery(at 72 hours after surgery)
- NRS scores for pain at rest and during movement(at 24，48 , 72 hours after surgery)
- incidence of PONV within 24 hours after surgery(during the first 24 hours after surgery)
- subjective sleep score (Sleep Quality Score (SQS))(At 1 week after surgery)
- quality of life QoR-15 scores at 1 and 3 months postoperatively(at 1 and 3 months after surgery)
研究者
Chunling Jiang
Professor
West China Hospital