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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: Completed NA study, sponsored by Hospital for Special Surgery, New York.

NCT02506673 is a NA study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Primary outcome will be number of skin conductance responses per second (SCR/sec) and amplitude of skin conductance responses averaged over time in 5 minute intervals and at key time points such before, during and after insertion of an IV, discussion with surgeon, anesthesiologist, immediately before leaving the holding area, immediately after entering the OR, during application of monitors, before and after administration of sedatives, before, during and after spinal insertion, incision, immedi

Interventions

  • DRUG Midazolam
  • DEVICE Zeiss, Cinema ProMED (audiovisual equipment)
  • DEVICE Skin Conductance Monitor

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2016-01-14
Est. Completion 2017-07
Phase NA

What the finished NCT02506673 record still lists

NCT02506673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.

NCT02506673 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02506673's enrollment target sits among peer trials

26 1710th of 2000 higher than 289 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02506673, the US trial registry maintained by the National Library of Medicine. NCT02506673 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.