Effect of the Built Operating Room Environment on Patient Outcome
Condition: Anxiety
Study type: Interventional

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.
    

Intervention name(s): SignatureSuite OR Integration System by STERIS Corporation
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): SignatureSuite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment