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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:
STERIS Corporation
Information provided by (Responsible Party):
Christian Burchill, The Cleveland Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Anxiety
Intervention: Device: SignatureSuite OR Integration System by STERIS Corporation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SignatureSuite OR

Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.

SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.

Standard OR Patients who's surgeon has been randomized into the standard operating room.

Participant Flow:   Overall Study
    SignatureSuite OR   Standard OR
STARTED   50   50 
COMPLETED   50   50 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Thyroid surgery cases

Reporting Groups
  Description
SignatureSuite OR

Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.

SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.

Standard OR Patients who's surgeon has been randomized into the standard operating room.
Total Total of all reporting groups

Baseline Measures
   SignatureSuite OR   Standard OR   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   100 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.7  (14.3)   53.3  (14.3)   52.5  (14.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      41  82.0%      43  86.0%      84  84.0% 
Male      9  18.0%      7  14.0%      16  16.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      1   2.0%      1   1.0% 
Not Hispanic or Latino      49  98.0%      48  96.0%      97  97.0% 
Unknown or Not Reported      1   2.0%      1   2.0%      2   2.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      2   4.0%      0   0.0%      2   2.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   6.0%      12  24.0%      15  15.0% 
White      41  82.0%      36  72.0%      77  77.0% 
More than one race      1   2.0%      2   4.0%      3   3.0% 
Unknown or Not Reported      3   6.0%      0   0.0%      3   3.0% 
Surgical site 
[Units: Participants]
Count of Participants
     
Parathyroid      16  32.0%      22  44.0%      38  38.0% 
Thyroid      34  68.0%      28  56.0%      62  62.0% 
Kindler Preoperative Anxiety Scale Total Score [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
 29.8 
 (15.8 to 55.2) 
 26.6 
 (8.6 to 44.1) 
 28.9 
 (10.3 to 47.9) 
[1] The Kindler preoperative anxiety scale quantifies 10 factors that cause preoperative anxiety. Each factor 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 on each factor. 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. The average of the scores represents the total preoperative anxiety score.
Past medical history diagnosis groups 
[Units: Participants]
     
cardiovascular/respiratory   13   19   32 
Other   15   19   34 
endocrine   49   48   97 
gastrointestinal/genitourinary   20   18   38 
neuromuscular   16   25   41 
Preoperative anxiety visual analog scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 36.3  (27.9)   32.0  (28.9)   34.13  (28.4) 
[1] The preoperative anxiety scale quantifies preoperative 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 preoperative 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.
Preoperative systolic blood pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 137.50  (17.4)   142.6  (19.8)   140.0  (18.7) 
Preoperative heart rate 
[Units: Beats per minute]
Mean (Standard Deviation)
 77.9  (12.7)   78.8  (15.3)   78.4  (14.0) 


  Outcome Measures

1.  Primary:   Change (Difference) in Anxiety   [ Time Frame: Pre-operatively to post-operatively ]

2.  Secondary:   Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures   [ Time Frame: Pre-operative to post-operative ]

3.  Secondary:   Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates   [ Time Frame: Pre-operative to post-operative ]

4.  Other Pre-specified:   Analgesic Use   [ Time Frame: Postoperatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was conducted at one community hospital in Northeast Ohio. Study population limited to patients having thyroid or parathyroid surgery. Low dose anxiolytic given intravenously in the preoperative holding area prior to being moved to the OR.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christian N. Burchill, PhD, RN, CEN
Organization: Cleveland Clinic
phone: 216-445-9317
e-mail: burchic@ccf.org



Responsible Party: Christian Burchill, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03037905     History of Changes
Other Study ID Numbers: CCF15-009
First Submitted: September 11, 2016
First Posted: January 31, 2017
Results First Submitted: September 15, 2017
Results First Posted: November 22, 2017
Last Update Posted: December 19, 2017