the Psychological Interventions for Alleviating Anxiety and Depressive Emotion Among Oocyte Retrieval Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The difference in incidence of anxiety 1 hour before operation between the two groups
研究概览
简要总结
The goal of this clinical trial is to learn if psychological interventions alleviate the anxious emotion of women undergoing oocyte retrieval operation with general anesthesia.
The main questions it aims to answer are:
If psychological interventions reduced participants' anxiety scores before the oocyte retrieval operation. Researchers will compare psychological interventions to no interventions to see if psychological interventions work to alleviate anxious emotion. Questionnaires related anxiety were completed online before surgery by participants.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •underwent oocyte retrieval operation with general anesthesia
- •able to use smartphone to complete questionnaire
排除标准
- •had major psychological trauma, schizophrenia
- •morbid obesity (BMI greater than 40.0 kg/m2.)
- •serious disease of cardiovascular system including uncontrolled hypertension
- •serious endocrine system disease including uncontrolled hypothyroidism
- •history of severe adverse events related to anesthesia
- •history of substance abuse or severe allergy
- •refusal to provide written consent
结局指标
主要结局
The difference in incidence of anxiety 1 hour before operation between the two groups
时间窗: Each patient is assessed by APAIS for two times. The first time is 24 hours before surgery, and the second time is 1 hour before surgery.
The degree of anxiety was measured by the Amsterdam Preoperative Anxiety and Information Scale and it is abbreviated as APAIS in the Primary Outcome. This is a six-item questionnaire. Every item is graded on a five-point scale from 1(meaning not at all) to 5 (meaning extremely). The scoring range of this scale is from 6 to 30 points, with a cutoff point of 11. Specifically, a score of ≤10 indicates no anxiety, while a score of ≥11 indicates anxiety. Each patient received two APAIS assessments, 24 hours before and 1 hour before surgery respectively. After the second assessment, the number of anxious patients in each group was calculated based on the APAIS scores. Then, the number of anxious patients divided by the total number of patients in the group is the incidence of anxiety. Finally, a statistical comparison was made to determine if there is a significant difference in incidence of anxiety between the two groups of patients.
次要结局
- the comparison of postoperative PHQ-9 scores between two groups(Each patient is assessed by PHQ-9 twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.)
- the comparison of incidence of postoperative anxiety between two groups(Each patient is assessed by GAD-7 twice.The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.)
- the comparison of postoperative GAD-7 scores between two groups(Each patient is assessed by GAD-7 twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.)
- the comparison of incidence of postoperative depression in two groups(Each patient is assessed by PHQ-9 twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.)
- the comparison of postoperative HADS scores between two groups(Each patient is assessed by HADS twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.)
- the comparison of APAIS score in two group 1h before operation(Each patient is assessed by APAIS for two times. The first time is 24 hours before surgery, and the second time is 1 hour before surgery.)
研究者
Qibin Chen
associate professor
First Affiliated Hospital of Chongqing Medical University