Clinical trial NCT03037905: Effect of the Built Operating Room Environment on Patient Outcome
Official title: Effect of the Built Operating Room Environment on Patient Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: STERIS Corporation
First posted: 2017-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Change (Difference) in Anxiety
timeFrame: Pre-operatively to post-operatively
Secondary outcomes:
measure: Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures
timeFrame: Pre-operative to post-operative
measure: Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates
timeFrame: Pre-operative to post-operative
Other outcomes:
measure: Analgesic Use
timeFrame: Postoperatively
Locations:
city: Garfield Heights
country: United States
facility: Cleveland Clinic Marymount Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Christian N Burchill, PhD
role: PRINCIPAL_INVESTIGATOR
References: