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OpenTrials
Active, Not Recruiting

NCT Number: NCT05633901

Impact of Preop Video on Patient Anxiety

To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prolapse, Vaginal Anxiety Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Mental Disorders Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Prolapse, Uterine Prolapse; Female Urogenital Diseases Uterine Diseases Uterine Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Urogynecology Associates, Cincinnati, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prolapse surgery may include: apical repair with uterosacral ligament suspension, or sacrospinous/iliococcygeal ligament fixation, or sacrocolpopexy.
  • They may also have a concomitant total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy, other compartment repairs for prolapse, or a suburethral sling for incontinence.
  • Surgery by one of the fellowship trained Urogynecologists at TriHealth
  • Age >= 18
  • English speaking
  • Able to comprehend and answer the survey completely.

Exclusion criteria

  • Concomitant procedure with another surgeon
  • Resides in a nursing home
  • Non-English speaking
  • Patients with mental disability, Alzheimer's disease, dementia that would preclude complete answering of the survey or inability to answer the questions.

Treatment and study plan

Educational Video

Other

Patients will be given the link to the educational video and able to view it as many times as they want

Standard counseling

Other

Current standard of care verbal counseling from a clinic nurse

Primary outcomes

  1. Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire.

    Time frame: Immediately Pre-op

    Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)

Secondary outcomes

  1. To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients currently taking medication for anxiety

    Time frame: Immediately Pre-op

    Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)

  2. To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients that did or did not watch the video at home

    Time frame: Immediately Pre-op

    Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Evaluation of Preoperative Counseling Video on Anxiety in Patients Undergoing Vaginal Prolapse Surgery

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2022
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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