- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364968
Impact of a Preoperative Instructional Video on Patient Preparedness
Evaluating the Impact of Randomized Preoperative Instructional Video on Patient Preparedness Following Minimally Invasive Gynecologic Surgery
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:
- Will the patients who watch the pre-operative will show decreased anxiety and uncertainty about their procedure when compared to the control group?
- 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?
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Riverside, California, United States, 92521
- University of Riverside, California
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
- Female
Exclusion Criteria:
- Receiving postoperative chemotherapy in the 6-week postoperative period
- Minors under the age of 18
- Postoperative overnight stay
- Laparotomy (open surgery)
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Study group of patients will be asked to watch an informational video.
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 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.
|
|
No Intervention: Study group of patients will receive standard of care
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient level of satisfaction with the education they received prior to surgery
Time Frame: 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.
|
6 months to one year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 23031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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