- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06265376
Do Patient Educational Videos Improve Pain and Recovery After Laparoscopic Hysterectomy?
August 22, 2024 updated by: Megan Loring, Benaroya Research Institute
A Single-site Randomized Controlled Trial of an Patient Educational Video to Improve Postoperative Pain and Overall Recovery Satisfaction After Laparoscopic Hysterectomy Benign Indication
The use of multi-model patient education has been used in a variety of medical specialties to educate patients on expectations for various medical procedures and improve patients' understanding of their own health care.
However, it is unknown what type of audio and/or visual materials work best in a given clinical setting.
By surveying overall pain/post-operative recovery satisfaction we can measure how well our video intervention educates and reinforces post-operative management at home when compared to the current method of education that patients receive at the pre-operative visit prior to laparoscopic hysterectomy at this institution.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18y/o or older
- planned for a laparoscopic hysterectomy for benign indications
Exclusion Criteria:
- inability to consent
- language other than English
- conversion to laparotomy, vNOTES (a type of laparoscopic assisted vaginal hysteroectomy)
- vaginal hysterectomy
- chronic opioid use prior to surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational Video Intervention
Participants have been randomly selected into this arm to receive intervention via the educational video in addition to regular treatment and recovery options.
|
A recorded educational video will be presented to the patient prior to meeting with the provider at the presurgical meeting
|
|
No Intervention: No Intervention
Participants have been randomly selected into this arm to not receive intervention and continue with regular treatment and recovery options.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy
Time Frame: Within 10 days post surgery
|
To determine if video education on post-operative pain management and expectations can improve patients' overall satisfaction with post operative pain control after laparoscopic hysterectomy
|
Within 10 days post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score at the time of survey completion (0=no pain 10=worst pain
Time Frame: Within 10 days post surgery
|
To determine if video education on post-operative pain management and expectations improves patient post operative pain scores at the time of post-op phone call
|
Within 10 days post surgery
|
|
Average pain score for the first 7 days as perceived by the patients (likert scale)
Time Frame: Within 10 days post surgery
|
To determine if video education on post-operative pain management and expectations improves patient perceived post operative pain control throughout the first 7 day post-op
|
Within 10 days post surgery
|
|
Number of post-op phone calls received
Time Frame: Within 10 days post surgery
|
To determine if video education on post-operative pain management and expectations decreases the number of post- operative phone calls received by providers during the first week post-op
|
Within 10 days post surgery
|
|
Number of post-op emergency room visits
Time Frame: Within 10 days post surgery
|
To determine if video education on post-operative pain management and expectations decreases the number of post- operative emergency room visits by patients during the first week post-op
|
Within 10 days post surgery
|
|
Number of readmissions
Time Frame: Within 10 days post surgery
|
To determine if video education on post-operative pain management and expectations decreases the number of postoperative readmissions by patients during the first week post-op
|
Within 10 days post surgery
|
|
Number of patients with steri-strips still in place
Time Frame: Within 10 days post surgery
|
To determine if video education on post-operative pain management and expectations decreases the number of patients who have not removed their steri-strips by day 7
|
Within 10 days post surgery
|
|
Number opioids taken since surgery
Time Frame: Within 10 days post surgery
|
To determine if video education on post-operative pain management and expectations decreased the number of narcotics used post-operatively
|
Within 10 days post surgery
|
|
Overall satisfaction with pre-operative education regarding surgery (5 point Likert scale)
Time Frame: Within 10 days post surgery
|
To determine if video education on post-operative pain management and expectations improves overall satisfaction with pre-operative education regarding surgery
|
Within 10 days post surgery
|
|
ding surgery (5 point likert scale) Overall satisfaction with educations regarding what to expect post-operatively (5 point Likert scale)
Time Frame: Within 10 days post surgery
|
To determine if video education on post-operative pain management and expectations improves overall satisfaction with educations regarding what to expect post-operatively
|
Within 10 days post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Megan Loring, MD, Virginia Mason Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2023
Primary Completion (Actual)
April 28, 2024
Study Completion (Actual)
April 28, 2024
Study Registration Dates
First Submitted
January 4, 2024
First Submitted That Met QC Criteria
February 10, 2024
First Posted (Actual)
February 20, 2024
Study Record Updates
Last Update Posted (Actual)
August 23, 2024
Last Update Submitted That Met QC Criteria
August 22, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB22-046
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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