CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Midazolam +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02506673
NCT02506673N/ACompleted

The Effect of Audiovisual Aids on Perioperative Stress Response, Pain and Overall Experience - a Randomized Controlled Pilot Study

Hospital for Special Surgery, New York·interventional·Posted Jul 23, 2015·Updated Dec 27, 2024

In Brief

A clinical study evaluating Zeiss, Cinema ProMED (audiovisual equipment), Midazolam, and 1 other intervention for Stress, Psychological. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 23, 2015
Enrollment StartJan 14, 2016
Primary CompletionMay 1, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.9 years ago

Interventions

Zeiss, Cinema ProMED (audiovisual equipment)device

Midazolamdrug

Skin Conductance Monitordevice