Impact of Educational Videos on Pre-operative Anxiety

NCT07740759 — Not applicable, Enrolling by invitation, 60 participants, UConn Health

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

Registry	NCT07740759
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	60 (Estimated)
Sponsor	UConn Health (Other)
Conditions	Endometriosis, Fibroids, Adenomyosis, Pelvic Pain, Abnormal Uterine Bleeding, Adnexal Mass, Minimally Invasive Gynecologic Surgery, Hysterectomy, Myomectomy, Ovarian Cystectomy, Adnexal Surgery
Interventions	educational video (Other)
Dates	start 2026-07-17, primary completion 2028-03-01 (estimated), completion 2028-03-01 (estimated), first posted 2026-08-03, last updated 2026-08-03
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Video group	Experimental	Other: educational video	This group will be provided the educational videos to watch before their preoperative appointment.
Usual care group	No intervention		This group will not be sent the educational videos before their preoperative appointment.

educational video (Other): 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.

+Outcome measures

Primary outcomes

Preoperative anxiety as measured by the State Trait Anxiety Inventory (STAI) [once, at the preoperative appointment]: 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.

Secondary outcomes

Preoperative patient preparedness [Once, at the preoperative appointment]: Preparedness will be measured by a patient preparedness questionnaire (PPQ). Preparedness will be determined by answering "strongly agree" to the last question on the PPQ ("Overall, I feel prepared for my upcoming surgery"). Preparedness will be analyzed using logistic regression models, also with and without covariate adjustment.

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
UConn Health	Farmington, Connecticut	United States

+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