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NCT02506673 · ClinicalTrials.gov registry record · NA
Audiovisual Aid Pilot Study
A NA study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT02506673 is a NA study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 26 participants.
The verdict
NCT02506673, a NA study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
Little is known about perioperative stress responses and possible anxiety mitigating factors like audiovisual aids or IV sedation. Most studies use surrogate markers and retrospective questionnaires, and are not based on real-time gathered data. Skin conductance measurements allow the sympathetic discharge to be evaluated down to fractions of a second and enable us to continuously monitor stress responses as skin conductance responses/per second during the perioperative management. In our study, the investigators propose to examine the effect of personal audiovisual equipment (audio/video goggles) on perioperative stress, pain, and overall experience in patients undergoing ambulatory meniscectomy under spinal anesthesia. Patients will be randomly assigned to either receive traditional sedation or light sedation in addition to audiovisual equipment. The investigators hope to determine outcome estimates of the use of this equipment on stress levels using skin conductance measurements, request for further sedation, postoperative pain levels and analgesic consumption, time to discharge readiness, and overall patient satisfaction, and collect thus far unavailable data on the stress response to perioperative stresses (such as IV insertion and spinal placement) in order to allow for power analyses for future studies.
Interventions
- DRUG Midazolam
- DEVICE Zeiss, Cinema ProMED (audiovisual equipment)
- DEVICE Skin Conductance Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2016-01-14 |
| Est. Completion | 2017-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02506673
The ClinicalTrials.gov registry entry for NCT02506673 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT02506673 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02506673 about?
NCT02506673 is a clinical study titled "Audiovisual Aid Pilot Study". Little is known about perioperative stress responses and possible anxiety mitigating factors like audiovisual aids or IV sedation. Most studies use surrogate markers and retrospective questionnaires, and are not based on real-time gathered data. Skin conductance measurements allow the sympathetic di...
What is the current status of trial NCT02506673?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2016-01-14. Estimated completion is 2017-07.
What interventions are being tested in trial NCT02506673?
The interventions under investigation include: Midazolam (DRUG), Zeiss, Cinema ProMED (audiovisual equipment) (DEVICE), Skin Conductance Monitor (DEVICE).
Who is sponsoring clinical trial NCT02506673?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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