CClinicalTrials.gg
Active, not recruitingNCT05633901Updated Nov 22, 2024

Impact of Preop Video on Patient Anxiety

An interventional study of Educational Video and Standard Counseling in Prolapse, Vaginal, Prolapse, Uterine and Prolapse; Female, sponsored by TriHealth Inc.. Active, not recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by TriHealth Inc. · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Prolapse, Vaginal
  • Prolapse, Uterine
  • Prolapse; Female

Keywords

  • Anxiety
  • Video
  • Prolapse
  • Urogynecology
03

In context

Uterine Prolapse

111 studies on the registry are indexed under Uterine Prolapse; 20 are open to participants now.

This study's planned enrollment of 160 is above the median of 70 across 81 interventional studies indexed under Uterine Prolapse.

Browse Uterine Prolapse studies →

Lead sponsor

TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
160 participants (estimated)

Study arms

  • Placebo comparator
    Standard of Care

    Standard verbal counseling provided to patients by clinic nurse about post-operative expectations

    Other: Standard Counseling

  • Active comparator
    Educational Video

    An educational video to aid standard counseling packet on post-operative expectations

    Other: Educational Video

Interventions

  • OtherEducational Video

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

  • OtherStandard Counseling

    Current standard of care verbal counseling from a clinic nurse

06

What researchers measure

Primary outcomes

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

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

    Time frame: Immediately Pre-op

Secondary outcomes

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

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

    Time frame: Immediately Pre-op

  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

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

    Time frame: Immediately Pre-op

07

Study locations

2 sites
  • Cincinnati Urogynecology Associates
    Cincinnati, Ohio 45220, United States
  • Good Samaritan Hospital
    Cincinnati, Ohio 45220, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05633901
Lead sponsor
TriHealth Inc.
Responsible party
Sponsor
First posted
Dec 1, 2022
Start date
Dec 7, 2022
Primary completion
Nov 6, 2024
Completion
Dec 2024 (estimated)
Last update
Nov 22, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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