NCT07740759

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress3%
Jul 2026Mar 2028

Study Start

First participant enrolled

July 17, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 22, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

minimally invasive gynecologic surgerypre-operative anxiety

Outcome Measures

Primary Outcomes (1)

  • Preoperative anxiety as measured by the State Trait Anxiety Inventory (STAI)

    The STAI will be used to survey the anxiety patients feel in relation to their upcoming surgery. An STAI score of ≥ 40 has been used to define clinical anxiety in the literature, so this will be the threshold to define clinically significant pre-operative anxiety. STAI scores will be compared between groups using linear regression models, both unadjusted and adjusted for any unbalanced baseline covariates.

    once, at the preoperative appointment

Secondary Outcomes (1)

  • Preoperative patient preparedness

    Once, at the preoperative appointment

Study Arms (2)

Video group

EXPERIMENTAL

This group will be provided the educational videos to watch before their preoperative appointment.

Other: educational video

Usual care group

NO INTERVENTION

This group will not be sent the educational videos before their preoperative appointment.

Interventions

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.

Video group

Eligibility Criteria

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

You may qualify if:

  • 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.)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

Related Publications (3)

  • 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: 18060968BACKGROUND
  • 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: 33787563BACKGROUND
  • 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: 26138522BACKGROUND

MeSH Terms

Conditions

EndometriosisLeiomyomaAdenomyosisPelvic PainMetrorrhagia

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUterine HemorrhageHemorrhagePathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

July 22, 2026

First Posted

August 3, 2026

Study Start

July 17, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations