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 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 Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Device: SignatureSuite OR Integration System by STERIS Corporation

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Garfield Heights, Ohio, United States, 44125
      • Cleveland Clinic Marymount Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SignatureSuite OR; The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.	Device: SignatureSuite OR Integration System by STERIS Corporation; 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.; Other Names: SignatureSuite
No Intervention: Standard OR; Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (Difference) in Anxiety	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.	Pre-operatively to post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures	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	Pre-operative to post-operative
Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates	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	Pre-operative to post-operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic Use	Number of people requiring analgesia in the post-anesthesia care unit	Postoperatively

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: STERIS Corporation
• Investigators: Principal Investigator: Christian N Burchill, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 11, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CCF15-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No data to be shared