Effect of the Built Operating Room Environment on Patient Outcome
Completed · Not applicable
Conditions studied: Anxiety
In brief
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.
Key facts
- Study ID
- NCT03037905
- Run by
- The Cleveland Clinic
- People needed
- 100
- Starts
- 2015-01-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2020-07-16
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- able to read and understand English;
- presentation for thyroid and/or parathyroid surgery at Marymount Hospital;
- visual capacity to complete the VAS
You may not qualify if…
- history of documented anxiety/depression disorder
- currently taking medications for depression/anxiety
- currently taking anticonvulsant medication and/or gamma-Aminobutyric acid analogs
- unable to read and understand English
- dementia
- vision loss making it impossible to complete the anxiety visual analog scale
- currently taking beta-blockers
- surgeon refusal for patient participation
- intra-operative emergency, such as cardiac incident requiring resuscitation or stabilizing medications, unplanned extubation, or early emergence from anesthesia
- other patient-related reasons that would affect eligibility to participate.
Where it is running
- Cleveland Clinic Marymount Hospital — Garfield Heights, Ohio, United States
Full record on ClinicalTrials.gov
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