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Effect of the Built Operating Room Environment on Patient Outcome

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ClinicalTrials.gov Identifier: NCT03037905
Recruitment Status : Completed
First Posted : January 31, 2017
Results First Posted : November 22, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Anxiety 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of the Built Operating Room Environment on Patient Outcome
Study Start Date : January 2015
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

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 Name: SignatureSuite
No Intervention: Standard OR
Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.


Outcome Measures

Primary Outcome Measures :
  1. Change (Difference) in Anxiety [ Time Frame: 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 :
  1. Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures [ Time Frame: 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

  2. Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates [ Time Frame: 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


Other Outcome Measures:
  1. Analgesic Use [ Time Frame: Postoperatively ]
    Number of people requiring analgesia in the post-anesthesia care unit


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037905


Locations
United States, Ohio
Cleveland Clinic Marymount Hospital
Garfield Heights, Ohio, United States, 44125
Sponsors and Collaborators
The Cleveland Clinic
STERIS Corporation
Investigators
Principal Investigator: Christian N Burchill, PhD The Cleveland Clinic
More Information

Responsible Party: Christian Burchill, Nurse Scientist II, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03037905     History of Changes
Other Study ID Numbers: CCF15-009
First Posted: January 31, 2017    Key Record Dates
Results First Posted: November 22, 2017
Last Update Posted: December 19, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data to be shared