Effect of the Built Operating Room Environment on Patient Outcome

NCT ID: NCT03037905

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-05-31

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SignatureSuite OR

The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.

Group Type: EXPERIMENTAL

SignatureSuite OR Integration System by STERIS Corporation

Intervention Type: DEVICE

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.

Standard OR

Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

SignatureSuite

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

STERIS Corporation

UNKNOWN

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Christian Burchill

Nurse Scientist II

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian N Burchill, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Marymount Hospital

Garfield Heights, Ohio, United States

Countries

United States

Other Identifiers

CCF15-009

Identifier Type: -

Identifier Source: org_study_id