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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06265376
Other study ID # IRB22-046
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 13, 2023
Est. completion date July 1, 2024

Study information

Verified date February 2024
Source Benaroya Research Institute
Contact Megan Loring, MD
Phone (206) 223-6191
Email Megan.Loring@virginiamason.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational Video
A recorded educational video will be presented to the patient prior to meeting with the provider at the presurgical meeting

Locations

Country Name City State
United States Virginia Mason Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Benaroya Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy 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 Pain score at the time of survey completion (0=no pain 10=worst pain 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
Secondary Average pain score for the first 7 days as perceived by the patients (likert scale) 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
Secondary Number of post-op phone calls received 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
Secondary Number of post-op emergency room visits 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
Secondary Number of readmissions 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
Secondary Number of patients with steri-strips still in place 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
Secondary Number opioids taken since 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
Secondary Overall satisfaction with pre-operative education regarding surgery (5 point Likert scale) 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
Secondary ding surgery (5 point likert scale) Overall satisfaction with educations regarding what to expect post-operatively (5 point Likert scale) 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
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