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NCT03037905 · ClinicalTrials.gov registry record · NA

Effect of the Built Operating Room Environment on Patient Outcome

A NA study, sponsored by The Cleveland Clinic.

Completed
Registry status
NA
Development phase
100
Enrollment target

NCT03037905: Completed NA study, sponsored by The Cleveland Clinic.

NCT03037905 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03037905, a NA study, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
NA
Development phase
100 participants
Enrollment target

Study 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.

Primary Outcome

Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety. It is measured on a 100 millimeter line with anchors "No anxiety" to "The most anxiety I can imagine." Participants make a mark across the line to represent their current state of anxiety. A millimeter ruler is used to measure from left to right with

Interventions

  • DEVICE SignatureSuite OR Integration System by STERIS Corporation

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2015-01
Est. Completion 2016-05
Phase NA
The Cleveland Clinic

688 total trials

What the finished NCT03037905 record still lists

NCT03037905 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which SignatureSuite OR Integration System by STERIS Corporation is the first listed.

NCT03037905 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03037905 about?

NCT03037905 is a clinical study titled "Effect of the Built Operating Room Environment on Patient Outcome". 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 mon...

What is the current status of trial NCT03037905?

This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2015-01. Estimated completion is 2016-05.

What interventions are being tested in trial NCT03037905?

The interventions under investigation include: SignatureSuite OR Integration System by STERIS Corporation (DEVICE).

Who is sponsoring clinical trial NCT03037905?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03037905's enrollment target sits among peer trials

100 840th of 2000 higher than 1,081 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 NCT03037905, the US trial registry maintained by the National Library of Medicine. NCT03037905 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.