Effect of the Built Operating Room Environment on Patient Outcome
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 12/21/2017 |
| Start Date: | January 2015 |
| End Date: | May 2016 |
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.
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.
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.
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.
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.
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