Effect of the Built Operating Room Environment on Patient Outcome

Not Applicable

Completed

Conditions: Anxiety

Interventions: Device: SignatureSuite OR Integration System by STERIS Corporation

Registration Number: NCT03037905

Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed Description: Problem: Anxiety prior to surgery is an expected emotion. Research has been conducted on methods to reduce anxiety prior to entering the operating room (OR). These studies have involved some form of distraction, almost all finding that some form of distraction prior to entering the OR decreases both physiologic signs and patient reports of anxiety. Very few of these studies have carried the intervention into the OR 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. The research question is: What is the effect of the SignatureSuite OR environment on patient anxiety and analgesic use? Study methods: The proposed study will be a two arm randomized controlled trial. Randomization will occur at the surgeon level, based on SignatureSuite operating room environment (experimental group) versus a standard Marymount Hospital operating room environment (control group).

Data collection: The study will take place in the perioperative department of Cleveland Clinic's Marymount Hospital. Patient anxiety will be measured before and after surgery using an anxiety visual analog scale (VAS). Data about patient characteristics will be retrieved retrospectively by chart review. The effect of SignatureSuite on OR time will also be determined.

Sample characteristics: The patient sample will comprise patients undergoing thyroid and/or parathyroid surgery at Cleveland Clinic Marymount Hospital.

Sample size: 40 subjects per group will provide adequate power to detect large effect sizes (0.80) and is feasible in a reasonable period of time.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

able to read and understand English;
presentation for thyroid and/or parathyroid surgery at Marymount Hospital;
visual capacity to complete the VAS

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SignatureSuite OR	SignatureSuite OR Integration System by STERIS Corporation	The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.

Primary Outcome Measures

Name	Time	Method
Change (Difference) in Anxiety	Pre-operatively to post-operatively	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 the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety.

Secondary Outcome Measures

Name	Time	Method
Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures	Pre-operative to post-operative	Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit
Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates	Pre-operative to post-operative	Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit