NCT06265376

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

January 4, 2024

Last Update Submit

August 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Pain score at the time of survey completion (0=no pain 10=worst pain

    Within 10 days post surgery

  • Average pain score for the first 7 days as perceived by the patients (likert scale)

    Within 10 days post surgery

  • Number of post-op phone calls received

    Within 10 days post surgery

  • Number of post-op emergency room visits

    Within 10 days post surgery

  • Number of readmissions

    Within 10 days post surgery

  • +4 more secondary outcomes

Study Arms (2)

Educational Video Intervention

EXPERIMENTAL

Participants have been randomly selected into this arm to receive intervention via the educational video in addition to regular treatment and recovery options.

Behavioral: Educational Video

No Intervention

NO INTERVENTION

Participants have been randomly selected into this arm to not receive intervention and continue with regular treatment and recovery options.

Interventions

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

Educational Video Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • y/o or older
  • planned for a laparoscopic hysterectomy for benign indications

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Megan Loring, MD

    Virginia Mason Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Gynecologist

Study Record Dates

First Submitted

January 4, 2024

First Posted

February 20, 2024

Study Start

March 13, 2023

Primary Completion

April 28, 2024

Study Completion

April 28, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations