Impact of Educational Videos on Anxiety Prior to Minimally Invasive Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Preoperative anxiety as measured by the State Trait Anxiety Inventory (STAI)
研究概览
简要总结
The goal of this clinical trial is to learn if educational videos can reduce pre-operative anxiety in patients undergoing minimally invasive gynecologic surgery. The main question it aims to answer are:
do patient education videos decrease preoperative anxiety? do patient education videos increase patient preparedness for surgery? Researchers will compare the group who watched the videos preoperatively to the group who only underwent the usual counseling at the preoperative visit to see if the results of a survey that measures anxiety and preparedness differ.
Participants will be randomly assigned to one of two groups: one group that will be asked to watch the educational videos and one group that will not. All participants will attend their pre-operative appointment as usual and complete a survey afterwards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking patients over the age of 18 who plan to undergo any of the following laparoscopic surgeries, which includes robotic-assisted laparoscopy, with a MIGS provider: diagnostic laparoscopy, laparoscopic endometriosis excision, adnexal surgery, laparoscopic myomectomy, total laparoscopic hysterectomy
- •Concomitant procedures permitted (such as bowel resection for endometriosis, hysteroscopy, dilation and curettage, cystoscopy, etc.)
排除标准
- •Pregnant patients
- •Incarcerated patients
- •Patients under the age of 18
结局指标
主要结局
Preoperative anxiety as measured by the State Trait Anxiety Inventory (STAI)
时间窗: once, at the preoperative appointment
The STAI will be used to survey the anxiety patients feel in relation to their upcoming surgery. An STAI score of ≥ 40 has been used to define clinical anxiety in the literature, so this will be the threshold to define clinically significant pre-operative anxiety. STAI scores will be compared between groups using linear regression models, both unadjusted and adjusted for any unbalanced baseline covariates.
次要结局
- Preoperative patient preparedness(Once, at the preoperative appointment)
研究者
Alexis Newmark
Assistant Professor of Obstetrics and Gynecology
UConn Health
