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临床试验/NCT07364968
NCT07364968已完成不适用

Evaluating the Impact of Randomized Preoperative Instructional Video on Patient Preparedness Following Minimally Invasive Gynecologic Surgery

University of California, Riverside1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2023年9月26日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
patient level of satisfaction with the education they received prior to surgery

研究概览

简要总结

In this study, the investigators will evaluate the impact of a pre-operative instructional video for patients undergoing minimally invasive gynecologic surgery. The video will educate patients to understand what to expect and how to take care of themselves after the procedure. The effectiveness of the video will be evaluated via a questionnaire to see if patients who watched the video had better recovery outcomes, greater understanding, and less anxiety when compared to the group of patients who did not watch the pre-operative video.

The two questions the investigators wish to address are:

  1. Will the patients who watch the pre-operative will show decreased anxiety and uncertainty about their procedure when compared to the control group?
  2. Will increased understanding of the information shared in the video result in less pain medication usage, less ambiguity and thus increased compliance with post-operative care instructions, and quicker recovery?

详细描述

The study group of patients will be asked to watch the informational video about what to expect after their procedure and instructions on how to recover. They will be encouraged to ask their provider any follow-up questions. A link to view the video an unlimited amount of times will be provided. The control group of patients will receive the standard patient education in place before the procedure and will also be able to ask to follow-up questions from their provider. All patients will receive a link to complete a preoperative questionnaire.

Both groups will be scheduled for their routine two-week postoperative visit. At this visit, the questionnaire will be given to the patients in the form of a link to a virtual questionnaire to evaluate for effectiveness of the pre-operative video.

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
Single (Participant)

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants/Sample Size: Female patients who have been recommended for minimally invasive gynecologic surgery. A total of 52 patients will be enrolled in this study at UCR Women's Health Clinic. Statistical power: To detect an effect size of 0.5 with a power of 0.8, a sample size of 52 participants was required.
  • Inclusion criteria:
  • Age 18 - 65 years old
  • Surgery with UCR Gynecology physician
  • Laparoscopic/robotic surgery
  • Same day discharge after surgery
  • Can read a survey in English

排除标准

  • Receiving postoperative chemotherapy in the 6-week postoperative period
  • Minors under the age of 18
  • Postoperative overnight stay
  • Laparotomy (open surgery)
  • Pregnancy

研究组 & 干预措施

Study group of patients will be asked to watch an informational video.

Active Comparator

They will be encouraged to ask their provider any follow-up questions. A link to view the video an unlimited amount of times will be provided.

干预措施: Study group of patients will receive standard of care (Other)

Study group of patients will receive standard of care

No Intervention

The group of patients will receive the standard patient education in place before the procedure and will also be able to ask to follow-up questions from their provider. All patients will receive a link to complete a preoperative questionnaire.

结局指标

主要结局

patient level of satisfaction with the education they received prior to surgery

时间窗: 6 months to one year

Our primary outcomes will be patient level of satisfaction with the education they received prior to surgery and its impact on post-operative care which will be measured by the standardized likert scale (1 to 5 scale where 1 = strongly disagree and 5= strongly agree). The survey will include the following objective and subjective measures: Tylenol tablets used (over two weeks), Ibuprofen tablets used (over two weeks), pain scale (1 to 5 scale where 1 = none and 5= very severe). Additional information will be collected from the patient's medical records (ie. office visit notes, telephone encounters, hospital laboratory results, pain medication refill requests). Patients should continue any medication regimen as instructed by their physician up to the day of surgery. Patients will be treated for complications as they would have been treated otherwise. Study duration period will be approximately six months.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Simko, M.D.

Principal Investigator

University of California, Riverside

研究点 (1)

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