Anxiety
Conditions
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.
Interventions
DEVICESignatureSuite 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.
Sponsors
STERIS Corporation
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (Difference) in Anxiety | Pre-operatively to post-operatively | Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures | Pre-operative to post-operative | Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit |
| Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates | Pre-operative to post-operative | Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit |
Other
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Use | Postoperatively | Number of people requiring analgesia in the post-anesthesia care unit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Standard OR Patients who's surgeon has been randomized into the standard operating room. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Standard OR | Total | SignatureSuite OR |
|---|---|---|---|
| Age, Continuous | 53.3 years STANDARD_DEVIATION 14.3 | 52.5 years STANDARD_DEVIATION 14.2 | 51.7 years STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 97 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Kindler Preoperative Anxiety Scale Total Score | 26.6 units on a scale | 28.9 units on a scale | 29.8 units on a scale |
| Past medical history diagnosis groups cardiovascular/respiratory | 19 participants | 32 participants | 13 participants |
| Past medical history diagnosis groups endocrine | 48 participants | 97 participants | 49 participants |
| Past medical history diagnosis groups gastrointestinal/genitourinary | 18 participants | 38 participants | 20 participants |
| Past medical history diagnosis groups neuromuscular | 25 participants | 41 participants | 16 participants |
| Past medical history diagnosis groups Other | 19 participants | 34 participants | 15 participants |
| Preoperative anxiety visual analog scale | 32.0 units on a scale STANDARD_DEVIATION 28.9 | 34.13 units on a scale STANDARD_DEVIATION 28.4 | 36.3 units on a scale STANDARD_DEVIATION 27.9 |
| Preoperative heart rate | 78.8 beats per minute STANDARD_DEVIATION 15.3 | 78.4 beats per minute STANDARD_DEVIATION 14 | 77.9 beats per minute STANDARD_DEVIATION 12.7 |
| Preoperative systolic blood pressure | 142.6 mm Hg STANDARD_DEVIATION 19.8 | 140.0 mm Hg STANDARD_DEVIATION 18.7 | 137.50 mm Hg STANDARD_DEVIATION 17.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 15 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 36 Participants | 77 Participants | 41 Participants |
| Sex: Female, Male Female | 43 Participants | 84 Participants | 41 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
| Surgical site Parathyroid | 22 Participants | 38 Participants | 16 Participants |
| Surgical site Thyroid | 28 Participants | 62 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Change (Difference) in Anxiety
Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of 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 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.
Time frame: Pre-operatively to post-operatively
Population: thyroid and/or parathyroid surgery patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SignatureSuite OR | Change (Difference) in Anxiety | -24.4 units on a scale |
| Standard OR | Change (Difference) in Anxiety | -17.6 units on a scale |
p-value: 0.295% CI: [-17.1, 3.7]Mixed Models Analysis
Secondary
Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates
Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit
Time frame: Pre-operative to post-operative
Population: Patients undergoing thyroid and/or parathyroid surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SignatureSuite OR | Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates | 3.1 beats per minute |
| Standard OR | Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates | 4.1 beats per minute |
p-value: 0.7695% CI: [-7, 5.1]Mixed Models Analysis
Secondary
Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures
Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit
Time frame: Pre-operative to post-operative
Population: Patients undergoing thyroid and/or parathyroid surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SignatureSuite OR | Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures | -4.2 mm Hg |
| Standard OR | Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures | -6.4 mm Hg |
p-value: 0.695% CI: [-5.9, 10.3]Mixed Models Analysis
Other Pre-specified
Analgesic Use
Number of people requiring analgesia in the post-anesthesia care unit
Time frame: Postoperatively
Population: Patients that have undergone thyroid and/or parathyroid surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SignatureSuite OR | Analgesic Use | 9 Participants |
| Standard OR | Analgesic Use | 10 Participants |
p-value: 0.83Wilcoxon (Mann-Whitney)