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NCT03966469 · ClinicalTrials.gov registry record
What is the Impact of the Presence of a Support Person on Informed Consent
A clinical trial of Surgery and Urinary Incontinence, sponsored by Hartford Hospital.
- Completed
- Registry status
- 82
- Enrollment target
- 1
- Study location
NCT03966469: Completed study of Surgery and Urinary Incontinence, sponsored by Hartford Hospital.
NCT03966469 is a study of Surgery and Urinary Incontinence that has completed, run by Hartford Hospital. The registered enrollment target is 82 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03966469, a study of Surgery and Urinary Incontinence, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- 82 participants
- Enrollment target
- 1
- Study location
Study Summary
In practice, the Investigators recommend that patients bring a family member or close friend to their pre-operative appointment to help with patient anxiety, comprehension, and informed decision-making. However, there is limited literature to support this recommendation. The investigators are exploring if having a support person present during this consent process impacts anxiety, satisfaction, knowledge, and preparedness for surgery.
Primary Outcome
We will measure anxiety with the Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire. Score ranges from 20 to 80 with higher values indicating higher anxiety.
Conditions Studied
Interventions
- OTHER Preoperative support person present
- OTHER Patient Present Only
Study Locations (1)
Connecticut
- Hartford Hospital - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2019-05-17 |
| Est. Completion | 2020-02-25 |
What the finished NCT03966469 record still lists
NCT03966469 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with Surgery appearing as the primary indexed condition, and to 2 interventions - of which Preoperative support person present is the first listed.
NCT03966469 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT03966469 about?
NCT03966469 is a clinical study titled "What is the Impact of the Presence of a Support Person on Informed Consent". In practice, the Investigators recommend that patients bring a family member or close friend to their pre-operative appointment to help with patient anxiety, comprehension, and informed decision-making. However, there is limited literature to support this recommendation. The investigators are explor...
What is the current status of trial NCT03966469?
This trial is currently completed. The enrollment target is 82 participants. The study started on 2019-05-17. Estimated completion is 2020-02-25.
What conditions does trial NCT03966469 study?
This clinical trial studies the following conditions: Surgery, Urinary Incontinence, Knowledge, Attitudes, Practice, Prolapse, Vaginal.
What interventions are being tested in trial NCT03966469?
The interventions under investigation include: Preoperative support person present (OTHER), Patient Present Only (OTHER).
Who is sponsoring clinical trial NCT03966469?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03966469 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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82 66th of 120 higher than 55 of 120 other Surgery trials
participants (enrollment target), bucketed by value
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