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Enrolling by invitation NCT07740759

Impact of Educational Videos on Pre-operative Anxiety

No phase Interventional Endometriosis Fibroids Adenomyosis Pelvic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: educational video.
Who it may be relevant to
Registry conditions: Endometriosis, Fibroids, Adenomyosis, Pelvic Pain. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Educational Videos on Anxiety Prior to Minimally Invasive Gynecologic Surgery

Overview

The goal of this clinical trial is to learn if educational videos can reduce pre-operative anxiety in patients undergoing minimally invasive gynecologic surgery. The main question it aims to answer are: do patient education videos decrease preoperative anxiety? do patient education videos increase patient preparedness for surgery? Researchers will compare the group who watched the videos preoperatively to the group who only underwent the usual counseling at the preoperative visit to see if the results of a survey that measures anxiety and preparedness differ. Participants will be randomly assigned to one of two groups: one group that will be asked to watch the educational videos and one group that will not. All participants will attend their pre-operative appointment as usual and complete a survey afterwards.

Interventions

  • Other educational video
    The videos provide an overview of the following topics: preoperative instructions, female pelvic anatomy, positioning during surgery, the uterine manipulator device, pelvic laparoscopy, total hysterectomy, and postoperative instructions.

Primary outcome measures

  • Preoperative anxiety as measured by the State Trait Anxiety Inventory (STAI) [Time frame: once, at the preoperative appointment]
Secondary outcome measures (1)
  • Preoperative patient preparedness [Time frame: Once, at the preoperative appointment]

Eligibility criteria

Inclusion criteria

  • English speaking patients over the age of 18 who plan to undergo any of the following laparoscopic surgeries, which includes robotic-assisted laparoscopy, with a MIGS provider: diagnostic laparoscopy, laparoscopic endometriosis excision, adnexal surgery, laparoscopic myomectomy, total laparoscopic hysterectomy
  • Concomitant procedures permitted (such as bowel resection for endometriosis, hysteroscopy, dilation and curettage, cystoscopy, etc.)

Exclusion criteria

  • Pregnant patients
  • Incarcerated patients
  • Patients under the age of 18

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • UConn Health — Farmington

Publications

  • Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059. PMID 18060968
  • Sassani JC, Grosse PJ, Kunkle L, Baranski L, Ackenbom MF. Patient Preparedness for Pelvic Organ Prolapse Surgery: A Randomized Equivalence Trial of Preoperative Counseling. Female Pelvic Med Reconstr Surg. 2021 Dec 1;27(12):719-725. doi: 10.1097/SPV.0000000000001049. PMID 33787563
  • Wilson CJ, Mitchelson AJ, Tzeng TH, El-Othmani MM, Saleh J, Vasdev S, LaMontagne HJ, Saleh KJ. Caring for the surgically anxious patient: a review of the interventions and a guide to optimizing surgical outcomes. Am J Surg. 2016 Jul;212(1):151-9. doi: 10.1016/j.amjsurg.2015.03.023. Epub 2015 Jun 2. PMID 26138522

Identifiers

NCT: NCT07740759 · 26-148-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗