Abnormal Uterine Bleeding, Adenomyosis, Adnexal Mass, Adnexal Surgery, Endometriosis, Fibroids, Hysterectomy, Minimally Invasive Gynecologic Surgery, Myomectomy, Ovarian Cystectomy, Pelvic Pain
Conditions
Keywords
minimally invasive gynecologic surgery, pre-operative anxiety
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.
Interventions
OTHEReducational 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.
Sponsors
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed