CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
SignatureSuite OR Integration System by STERIS Corporationdevice
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/NCT03037905
NCT03037905N/ACompleted

Effect of the Built Operating Room Environment on Patient Outcome

The Cleveland Clinic·interventional·Posted Jan 31, 2017·Updated Jul 16, 2020

In Brief

A clinical study evaluating SignatureSuite OR Integration System by STERIS Corporation for Anxiety. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Anxiety prior to surgery is an expected emotion. Research has not been conducted on methods to reduce anxiety in the operating room itself. STERIS Corporation has developed an automated surgical suite environmental system, called SignatureSuite™, that controls the level of lighting, images on OR monitors, and ambient background audio via preset, computerized automation for use before and after anesthesia. This study aims to determine if this new type of operating room environment decreases anxiety, as measured by patient responses on anxiety visual analog scales, heart rate, systolic blood pressure, and postoperative analgesic use. The proposed study will be a two-arm, randomized controlled trial comparing anxiety levels for patients that have thyroid or parathyroid surgery in the SignatureSuite room at Cleveland Clinic Marymount Hospital versus the standard operating room environment. Randomization will occur at the surgeon level. There will be a maximum 100 patients divided equally between the experimental and control arms of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnxiety
CountriesUnited States
CollaboratorsSTERIS Corporation

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 31, 2017
Enrollment StartJan 1, 2015
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.4 years ago

Interventions

SignatureSuite OR Integration System by STERIS Corporationdevice

SignatureSuite OR Integration System by STERIS Corporation is a device that controls audio and visual components of the operating room environment in order to provide a more relaxing and calming operating room environment for patients prior to surgery and on emergence from anesthesia after surgery.