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Completed

NCT Number: NCT02076360

RCT: Impact of Preop Video on Patient Preparedness for Surgery

This is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical trial at one institution evaluating the use of a preoperative patient education video as an adjunct to preoperative counseling on patient-centered outcomes.

The aim of this study is to determine the impact of a preoperative patient educational video as an adjunct to the routine preoperative visit on patients' preparedness for surgery, perception of time spent with their healthcare team, and ultimately their satisfaction after surgery. The aim of this video is not to limit the doctor patient interaction (as all patients will still be granted their pre-allotted 30 minute visit with the physician regardless of their intervention allocation) but rather to augment the visit with additional educational information in an attempt to optimize the visit.

Objective:

A. Primary Aim(s):

• To determine if patients feel more prepared for surgery with addition of preoperative patient education video

B. Secondary Aim(s):

* To determine if addition of preoperative patient education video correlates with improved patient satisfaction after surgery * To determine if patients' perception of time spent with healthcare team in preparation for surgery increases with addition of patient educational video * To determine if actual patient-physician time spent counseling differs between groups * To determine if patient preparedness is correlated with objective surgical outcomes * To determine if patient preparedness is correlated with patient symptom improvement scores after surgery

Hypothesis:

The addition of a preoperative patient education video enhances patient preparedness for surgery, increases perception of the amount of time patients spend with healthcare team, and improves patient satisfaction.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida Urogynecology clinic

Tampa, Florida, 33606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women >18 scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy
  • It is acceptable if concomitant procedures such as suburethral slings or additional vaginal repairs are planned
  • English speaking
  • Willing and able to provide written and informed consent

Exclusion criteria

  • Women <18
  • Not scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy
  • Non-English speaking
  • Unable or unwilling to provide written and informed consent

Treatment and study plan

Preoperative Video

Behavioral

Patients will watch preoperative instructional video

Primary outcomes

  1. patients' preparedness for surgery

    Time frame: prior to surgery (baseline)

    patients' feelings of preparedness for surgery as determined by a preoperative patient preparedness questionnaire for pelvic surgery

  2. Patient preparedness for surgery

    Time frame: 2 week postop visit

    patients' feelings of preparedness for surgery as determined by a postoperative patient preparedness questionnaire for pelvic surgery

Secondary outcomes

  1. patient satisfaction

    Time frame: 2 weeks postop

    patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire

  2. perception of time

    Time frame: prior to surgery (baseline)

    patients' perception of time spent with healthcare team

  3. Actual facetime spent

    Time frame: prior to surgery (baseline)

    Actual facetime spent between physician and patient during preoperative counseling session measured in minutes

  4. QOL

    Time frame: 2 weeks postop

    Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])

  5. POPQ

    Time frame: 2 weeks postop

    Objective measures of success will be determined using the Pelvic organ prolapse quantification (POPQ to quantify prolapse)

  6. Patient satisfaction

    Time frame: prior to surgery (baseline)

    patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Impact of Preoperative Patient Education Video on Patient Preparedness After Sacrocolpopexy: A Single Blind Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2014
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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