Prolapse, VaginalNCT05633901
Impact of Preop Video on Patient Anxiety
A study testing Educational Video and Standard Counseling in people with Prolapse, Vaginal and Prolapse, Uterine, run by TriHealth Inc. at 2 sites in United States.
Trial summary
To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolapse, Vaginal, Prolapse, Uterine, Prolapse; Female
- What is being tested?
- Educational Video and Standard Counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Dec 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
Good Samaritan Hospital
Cincinnati, Ohio, 45220
About this study
Official title: Evaluation of Preoperative Counseling Video on Anxiety in Patients Undergoing Vaginal Prolapse Surgery
To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery
- Conditions
- Prolapse, Vaginal, Prolapse, Uterine, Prolapse; Female
- Being tested
- Educational Video, Standard Counseling
- Keywords
- Anxiety, Video, Prolapse, Urogynecology
- Medical subject headings
- Uterine Prolapse, Prolapse, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational VideoOther
Patients will be given the link to the educational video and able to view it as many times as they want
Standard CounselingOther
Current standard of care verbal counseling from a clinic nurse
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Placebo comparator | Standard verbal counseling provided to patients by clinic nurse about post-operative expectations Receives: Other: Standard Counseling |
| Educational Video | Active comparator | An educational video to aid standard counseling packet on post-operative expectations Receives: Other: Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Immediately Pre-op
Secondary outcomes (2)
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)
Measured: Immediately Pre-op
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)
Measured: Immediately Pre-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start7 Dec 2022
- Primary completion6 Nov 2024
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse, VaginalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633901
- Sponsor's protocol ID
- 22-094
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2022
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preoperative Counseling Video on Anxiety in Patients Undergoing Vaginal Prolapse Surgery
- ClinicalTrials.gov ID
- NCT05633901
- Acronym / sponsor ID
- 22-094
- Conditions
- Prolapse, Vaginal, Prolapse, Uterine, Prolapse; Female
- Keywords
- Anxiety, Video, Prolapse, Urogynecology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Placebo comparator | Other: Standard CounselingStandard verbal counseling provided to patients by clinic nurse about post-operative expectations |
| Educational Video | Active comparator | Other: Educational VideoAn educational video to aid standard counseling packet on post-operative expectations |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational VideoPatients will be given the link to the educational video and able to view it as many times as they want | Other | Educational Video |
| Standard CounselingCurrent standard of care verbal counseling from a clinic nurse | Other | Standard of Care |
Primary outcome
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)
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video and Standard Counseling in people with Prolapse, Vaginal and Prolapse, Uterine, run by TriHealth Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire. (time frame: Immediately Pre-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.