N/A
N=100
Effect of the Built Operating Room Environment on Patient Outcome
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03037905 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Change (Difference) in Anxiety — -24.4; -17.6 units on a scale — p=0.20
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SignatureSuite OR Integration System by STERIS Corporation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change (Difference) in Anxiety |
-24.4; -17.6 | 0.20 |
| SECONDARY Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures |
-4.2; -6.4 | 0.60 |
| SECONDARY Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates |
3.1; 4.1 | .76 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03037905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.