EndometriosisNCT07740759
Impact of Educational Videos on Pre-operative Anxiety
A study testing educational video in people with Endometriosis and Fibroids, run by UConn Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Fibroids, Adenomyosis
- What is being tested?
- educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2026to Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- Pregnant patients
- Incarcerated patients
- Patients under the age of 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Educational Videos on Anxiety Prior to Minimally Invasive Gynecologic Surgery
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.
- Conditions
- Endometriosis, Fibroids, Adenomyosis, Pelvic Pain, Abnormal Uterine Bleeding, Adnexal Mass
- Being tested
- educational video
- Keywords
- minimally invasive gynecologic surgery, pre-operative anxiety
- Medical subject headings
- Endometriosis, Leiomyoma, Adenomyosis, Pelvic Pain, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational videoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Video group | Experimental | This group will be provided the educational videos to watch before their preoperative appointment. Receives: Other: educational video |
| Usual care group | No intervention | This group will not be sent the educational videos before their preoperative appointment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: once, at the preoperative appointment
Secondary outcomes (1)
Preoperative patient preparedness
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.
Measured: Once, at the preoperative appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start17 Jul 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis Newmark, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740759
- Sponsor's protocol ID
- 26-148-1
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 18060968Sassani 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.
PubMed 33787563Wilson 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.
PubMed 26138522