Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel: a Single-blind Randomized Controlled Trial
Phase: NA
Conditions: Ultrasound
Sponsor: Brooke Army Medical Center

Heated Ultrasound Gel Satisfaction (HUGS): A Randomized Control Trial 
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1.  PROTOCOL TITLE:  Heated Ultrasound Gel Satisfaction (HUGS): A Randomized Control Trial 
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2.  ABSTRACT:  Ultrasound has become one of the fastest growing diagnostic tools for Emergency 
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Physicians, and given the increasing focus on patient satisfaction in the Emergency Department, there may 
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be opportunities to enhance both patient satisfaction and diagnostic accuracy. The purpose of this single-
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blind, randomized control trial will be to investigate whether simply having warm gel, as compared to room-
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temperature gel, during a bedside ultrasound significantly improves patient satisfaction scores. If satisfaction 
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scores are significantly higher, then medical directors may find it beneficial to invest in ultrasound gel 
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warmers. We will also investigate two secondary hypotheses: 1) patient perceptions of their medical 
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providers and 2) the overall quality of ultrasound images obtained. 
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3.  OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS.  
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Hypothesis: The utilization of warmed ultrasound gel significantly increases patient satisfaction with regards 
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to their care during a visit to the Emergency Department. 
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Null: The utilization of warmed ultrasound gel does not change patient satisfaction with regards to their care 
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during a visit to the Emergency Department.  
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Hypothesis 2: Utilization of warmed ultrasound gel significantly improves the quality of images obtained 
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during bedside ultrasound. 
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Null: The utilization of warmed ultrasound gel does not change the quality of images obtained during 
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bedside ultrasound.  
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Hypothesis 3: The utilization of warmed ultrasound gel significantly increases patient perceptions of their 
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physician’s professionalism. 
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Null: The utilization of warmed ultrasound gel does not change patient perceptions of physician 
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professionalism.  
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4.  MILITARY RELEVANCE.  Patient satisfaction as an indicator of the quality of healthcare has evolved as 
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an outcome measure within both the federal and civilian sectors. In fact, the DOD military health system 
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incorporated patient satisfaction surveys to serve as a measure for how its beneficiaries perceive their care. 
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6  In order to further review specific factors that may help to improve patient satisfaction scores, this study 
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will explore the use of warmed ultrasound gel and perceived patient satisfaction. For most soldiers and 
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dependents, warmed ultrasound gel is generally more comfortable than room temperature gel because 
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warmed gel appears to enhance patient comfort and improve overall experience with the procedure. There 
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is a considerable gap in the literature regarding factors that improve enhanced patient comfort in military 
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beneficiary populations.  Therefore, one of the contributions of this study will be to clarify precisely what that 
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level of satisfaction is, if use of warmed gel is truly a satisfaction factor, and if the quality of images improve 
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with the use of warmed gel. Generally, we aim to contribute to the generalizable knowledge of medical 
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science, particularly in regards to patient satisfaction and the impact of warmed gel on ultrasound imaging, 
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which would be applicable to both military and civilian settings. 
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5. BACKGROUND AND SIGNIFICANCE.  Patient satisfaction is a growing center focus of Emergency 
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Departments across the country. One study evaluated over 2.4 million ED visits over the course of four 
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Brooke Army Medical Center 
Institutional Review Board 
 
HUMAN SUBJECTS RESEARCH  
 PROTOCOL APPLICATION – Part B 

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years in eight different states. Their data showed that patients who responded with the lowest quarter of 
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satisfaction scores were twice as likely to file a complaint compared to the top quarter of patients surveyed.1 
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In a 2005 study in JAMA, 93% of physicians in Pennsylvania from six of the most litigious medical services 
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reported that they practice “defensive medicine and within this group, ED physicians had the highest rates of 
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ordering more tests than medically necessary.2  
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In line with the concept of more tests than medically necessary, CT orders in the ED are becoming standard 
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of practice as a method of evaluating a wide variety of complaints. Levin, Parker, and Fragos (2014) 
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reported that for every 1000 Medicare ED visits between 2002-2012, CT scanner use increased remarkably 
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across the country.3 The doses of radiation that come with CT scans, however, can increase the risk to the 
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patient in the long run. For example, one abdominal CT delivers 8mSv, which is roughly equivalent to the 
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radiation from 400 chest xrays.4 To counter this increase in CT scans, ultrasound has become one of the 
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fastest growing and safer diagnostic tools for ED physicians over the past decade. Non-cardiac ultrasound 
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use increased by 121% from 2002-2012, with 21 patients per 1000 being scanned.3 With real-time 
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diagnostic capabilities at the bedside and no harmful radiation, ultrasounds provide clinicians with decision 
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tools to better care for their patients. Class I medical devices, such as the Thermasonic® Gel Warmer, heat 
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ultrasound gel to- and just-above normal body temperatures are frequently seen in Cardiology and OB-GYN 
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clinics, where echocardiograms and pelvic ultrasounds are performed routinely. Given the increase in use of 
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ultrasound and the increased focus on patient satisfaction, our aim is to identify whether warmed gel can 
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truly improve overall patient satisfaction when performing point-of-care ultrasounds in the ED. 
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6.  RESEARCH DESIGN   
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This is a single-blinded, randomized study will recruit a sample of 124 subjects from military and civilian 
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populations who are treated in the Emergency Department (ED) at SAMMC and require standard of care 
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bedside ultrasound for diagnosis. 
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7.  RESEARCH PLAN 
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7.1 Selection of Subjects 
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7.1.1. Subject Population. 
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7.1.2 Inclusion Criteria: 
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 
Adults 18-89 who are seen in the SAMMC Emergency Department that require standard of care 
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bedside ultrasound  
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7.1.3 Exclusion criteria: 
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 
Minors under age 18 
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 
Pregnant females 
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 
Adults over age 90 
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Vulnerable adults to include those with altered mental status, incarcerated, military basic trainees, or 
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those with a primary language other than English 
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Patients with open or broken skin 
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7.1.2. Source of Research Material.  
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Source of Research Material 
 
Clinical Purposes(Y/N) 
Research Purposes (Y/N) 
 
Patient Survey 
N 
Y 
Provider Survey 
N 
Y 
 
Bedside Ultrasound 
Y (standard of care) 
Y 
 
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7.1.3. Description of the Recruitment and Prescreening Process.  Patients being treated in the ED who 
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require a standard of care bedside ultrasound for diagnosis will be approached by the AI (ultrasonographer). 
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The AI will advise patient that they are there to perform the ultrasound as ordered by his or her doctor and 
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subsequently ask if the patient would be interested in participating in a patient satisfaction survey surrounding 
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the ultrasound. If the patient says they are interested and meets inclusion/exclusion criteria, the AI will provide 
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the patient with the information sheet (see Appendix C) and explain the study to subject.   
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7.1.4. Subject Screening Procedures. N/A 
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7.1.5. Consent Process. In a private exam area in the ED, the AI will inquire whether the patient, who required 
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bedside ultrasound and who meets inclusion/exclusion criteria, would be interested in learning about a research 
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study involving how ultrasounds are performed.  The AI will provide an information sheet about the study to 
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interested patients.  If the patient is interested, the AI will review the information sheet (Appendix C) and answer 
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any questions the patient may have.   We are requesting a waiver of documentation of consent for this project 
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as the study procedures are minimal risk and involves no procedures for which written consent is normally 
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required outside the context of research. 
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Because we are not using or collecting any personally identifiable information for research purposes, a HIPAA 
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authorization does not apply to this research. 
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7.1.6. Compensation for participation.  None 
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7.2 Drugs, Dietary Supplements, Biologics, or Devices.   
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7.2.1 N/A  
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7.2.2  The Thermasonic Gel Warmer (Model 82-03 LED, 120V) is a Class I medical device that warms up to 
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three (3) gel bottles to settings of “Low” (97 Fahrenheit), “Medium” (102 Fahrenheit), or “High” (109 
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Farenheit) (Appendix E). For this study, we will set all gel warmers to the “Medium” setting. For a full listing 
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of the device instruction manual, please visit http://www.parkerlabs.com/thermasonic. 
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A heat-resistant glove, ULine Terry Cloth Glove (Appendix F), will be used by the AI to handle the 
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ultrasound gels. This glove is manufactured to resist temperatures up to 250 degrees Fahrenheit. In line 
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with SAMMC’s infection control practices and patient safety, ultrasound operators will wear a sterile glove 
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over the terry cloth glove to prevent the spread of microbiota from subject to subject. For more information 
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about the glove, please visit their website at http://uline.com/BL_111/terry-gloves. 
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7.3. Study Procedures/Research Interventions.  The principal investigator will brief ED physicians on details 
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of this study by email (Appendix D). ED physicians who identify that a patient will require an ultrasound will 
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page the ultrasound team as part of standard of care. At that time, the AI (ultrasonographer) will ask subject if 
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he/she would like to participate in a research study involving patient satisfaction and diagnostic bedside 
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ultrasound. If the patient agrees, the AI will provide an information sheet (Appendix C) and explain study 
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details/answer any questions. The patient will then be randomized and assigned a HUGS-X number that will be 
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placed in the comments section of the ultrasound image and given a 3-question patient survey (Appendix A) 
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related to patient satisfaction and perceptions about their provider which will be completed at the end of the 
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ultrasound procedure. The patient will be instructed not to provide any PII/PHI when he/she completes the 
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survey after the diagnostic beside ultrasound and to hand it back to the AI when complete.  
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Ultrasound and Warm or Room Temp Gel Procedures:  
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The AIs will use either the warm or cold gel to complete their standard of care diagnostic ultrasound scans. 
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Subjects will be randomized to receive either warm or cold gel depending on the study packet number. The 
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study packet number will contain specific randomized instructions for the AI that provides the appropriate gel 
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numbered 1-6 to utilize and the 3-question patient survey and 1 question provider survey.  
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Patients and providers will be blinded to the intervention meaning both the AI and the patient will be 
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unaware of different gel temperatures being utilized until the moment it is used on the patient’s ultrasound 
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area.  
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The provider (AI) will be blinded to the intervention used in two ways. The first being that six ultrasound gel 
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warmers, labeled #1-6, will be set up at a station, and the warmers will have been randomly set-up as far 
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which are actually turned on or not by the PI. The AI will not know which are turned on because the indicator 
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lights will be covered with black tape. Additionally, the AI will use heat-resistant gloves to hold the 
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ultrasound gel bottle as described in section 7.2.2. At the end of the subject’s bedside ultrasound, the 
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physician completing the ultrasound will hand the patient a satisfaction survey utilizing visual analog scales. 
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As an additional measure to test our blinding measure, the AI will complete the one question survey to test 
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whether he or she was aware of the warm or room-temperature gel temperature. 
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Both surveys will be collected and stored in a locked box in C-Pod of the Emergency Department until 
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results can be entered in to the electronic spreadsheet (HUGS DataTracker Data Collection Spreadsheet, 
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Appendix G) 
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The Ultrasound Image Rating:  
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Ultrasound image rating is conducted weekly by the SAMMC ED/Ultrasound Quality Assurance Team on a 
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weekly basis. These meetings are already a standard practice in our department to review every ultrasound 
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obtained in the department as a way to obtain feedback from all clinicians about the quality of their 
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ultrasound studies. Their standard metric for evaluation is a 5-point Likert-type scale. During this QA review, 
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scores related to images that have a HUGS ID in the comments area will be written down and provided to 
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the PI.   Their standard metric for evaluation is a 5-point Likert-type scale.  
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Table I: Summary of Study Activity/Interventions 
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Assessment: 
During 
ED Visit: 
Weekly Ultrasound QA Session: 
Screening            
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Randomization 
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Bedside Ultrasound 
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Anonymous Patient Survey Appendix A) 
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Provider Survey (Appendix B) 
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Review of Ultrasound Images for Overall Quality  
 
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7.3.1 Collection of Human Biological Specimens.  N/A  
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7.3.1.1 Laboratory evaluations and special precautions. N/A 
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7.3.1.2 Specimen storage. N/A  
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7.3.2 Data Collection.  Subject specific data (patient age, gender, and their satisfaction scores) will all be 
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written on the anonymous survey (Appendix A). The primary outcome will be a visual analogue scale, i.e. 
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continuous variable.  By collecting a variable with greater data density than a conventional Likert scale (e.g., 
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ordinal data), this will enable us to use more powerful statistical techniques in analyzing our data so minimizing 
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the possibility of a type II (beta) error. We will further evaluate our secondary outcomes with Likert-type scales 
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to minimize millimeter differences between patient scores. Finally, we will use binary data to evaluate whether 
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patients were overall satisfied with their visit. 
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Primary Outcome #1a: Overall, how satisfied are you with the experience of having a bedside ultrasound today? 
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 
Ranges from “Least” to “Most” on 10cm VAS (continuous data) 
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Primary Outcome #1b: Overall, are you satisfied with the care you received today in the Emergency 
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Department? 
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“Yes” or “No” (binary data) 
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Secondary Outcome #1: Overall, how professional was the physician who did your bedside ultrasound? 
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 
Ranges from “Least” (1) to “Most” (5) on 5-point Likert-type scale (ordinal data) 
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The subject survey form will not contain any PHI/PII. Completed packets will be taken to the locked bin in C-Pod 
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of the Emergency Department. We will also store the completed provider surveys in the same container to allow 
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for further evaluation of provider answers regarding which type of gel they believe they used and if the blinding 
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method imposed by the PI prevented the provider from knowing which gel they utilized.  
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New study packets will be kept in a separate designated bin within the Emergency Department, next to the 
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ultrasound gel warmers, so that associate investigators may access all required materials while working in the 
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department. The PI or available AI will pick up completed packets weekly and will either log the data 
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immediately or store them in the designated locked bin in the ultrasound team room until they can be entered 
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into the HUGS DataTracker spreadsheet.  
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Subject bedside ultrasounds, like any clinical ultrasound done in our hospital, are uploaded automatically to the 
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IMPAX system. Each week, the SAMMC ED/Ultrasound Quality Assurance Team reviews all bedside 
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ultrasounds for quality assurance purposes. Their standard metric for evaluation is a 5-point Likert-type scale. 
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This type of data is ordinal (and is the basis for secondary outcome #2).These scores will be logged by the PI or 
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available AI into an Excel Spreadsheet found on a password-protected computer behind a locked door in the 
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ultrasound team room. As all investigators are blinded to which ultrasounds were conducted with warm or cold 
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gel, there is no concern for a bias regarding the rating of quality for each ultrasound or during entering survey 
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data to the HUGS DataTracker. Upon transfer of all data to the spreadsheet, the paper surveys and hand-
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written scores for each ultrasound will be shredded.  
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7.4 Statistical Consideration 
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7.4.1 Sample Size Estimation.  This study will be developed to assess our primary outcome with a two-tailed 
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alpha of 0.05 and a beta of 0.2 (power of 0.8), with equal numbers in the warm and cold gel groups. Based on 
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previous studies on visual analog scales and patient satisfaction in the Emergency Department, we will be using 
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an effect size of 0.11 (indicating 11mm on the VAS) with a standard deviation of 0.21 (indicating 21mm on the 
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VAS).5 
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Estimate Required Sample Size 
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Estimate Subject Drop Out / Withdrawal 
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Total Enrollment Requirement 
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Enrollment at Each Site 
 
BAMC 
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7.4.2 Primary (i.e., primary outcome variables) and secondary endpoints. As discussed in 7.4.1, this study 
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has been powered to detect an effect size of 11mm on the VAS for a statistically significant difference when 
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investigating our primary outcome (1a). 
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#1a: Overall, how satisfied are you with the experience of having a bedside ultrasound today? 
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 
Ranges from “Least” to “Most” on 10cm on VAS 
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#1b: Overall, are you satisfied with the care you received today in the Emergency Department? 
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 
“Yes” or “no” 
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#2: Overall quality of images 
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 
Ranges from lowest quality (1) to highest quality (5) on a Likert-type scale 
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#3: Overall, how professional was the physician who did your bedside ultrasound? 
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 
Ranges from “Least” (1) to “Most” (5) on Likert-type scale 
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7.4.3 Data analysis. The patient satisfaction scores will be compared (warm vs. cold groups) using 
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independent sample t-tests. If the data are ordinal or not normally distributed with equal variances, the 
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equivalent non-parametric test will be used. Independent sample t-tests will also be used to compare the quality 
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ratings of the ultrasound images. 
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7.5 Confidentiality.  The PI or available AI will pick up completed packets weekly and will either log the data 
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immediately or store them in the designated locked bin in the ultrasound team room until they can be entered 
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into the HUGS DataTracker spreadsheet. It will not be possible to associate survey forms with patient charts.  
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Data from the anonymous surveys will be entered into an Excel Spreadsheet (HUGS DataTracker, Appendix G) 
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which will be stored on a password protected computer behind a locked door. The completed paper surveys will 
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be immediately shredded once entered electronically. Once the data has been analyzed, the anonymous data 
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file will be deleted. 
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The bedside ultrasounds, which are part of routine clinical care in our department, are stored within the 
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electronic IMPAX database. All completed ultrasounds for the past week within our emergency department are 
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automatically queued for review by our ultrasonography team. This process in inherent in our system and is not 
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specially designed for this research. They will know that an ultrasound study is part of the research study as the 
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“HUGS” identifier will be seen in the comments box of the ultrasound images. Only medical providers within the 
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military healthcare system have access to these scans.  
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7.5.1 Certificate of Confidentiality.  N/A   
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8.0 RISKS/BENEFITS ASSESSMENT 
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8.1 Risks.  There are minimal risks for this study. Although this survey is anonymous and cannot be tracked 
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to specific individuals, there is a small risk of inadvertent breach of confidentiality. Participants will not be 
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identified and will be reminded not to add identifiers to their survey documents. For the ultrasound images 
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on IMPAX, only military providers within the military healthcare system have access. Risk of a confidentiality 
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risk is similar to the normal, daily risk of breach in our healthcare system.  
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There is also the risk of brief discomfort to subjects related to the gel temperature.  Medical devices heat the 
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gel to a maximum temperature of 104 degrees. Injuries from gel at this temperature or at room temperature 
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are very unlikely to occur.  
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 
Although there is a minimal risk of gel being contaminated with microbiota, we will further mitigate the risk by 
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excluding patients with broken skin in the area of where an ultrasound probe would be placed onto the skin. 
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8.2 Potential Benefits.  There may be be direct benefits to participants.  Subjects enrolled in the warm gel 
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group may benefit from a more comfortable ultrasound.  
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9.0 ADVERSE EVENTS, UNANTICIPATED PROBLEMS, AND DEVIATIONS 
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9.1 An adverse event in this study would be either a burn to the patient, infection, or a breach of confidentiality. 
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These are considered rare but serious, as described above. Adverse events during the study would be 
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documented by the ultrasonographer or another member of the research team and reported by the PI to the IRB 
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as required. 
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9.2 Reporting Unanticipated Problems Involving Risks to Subjects or Others, Serious Adverse Events and 
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Deaths to the Office of the IRB, BAMC.   
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All unanticipated problems involving risk to subjects or others, serious adverse events, and all 
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subject deaths related to the study will be reported within 48 hours of the research team’s 
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knowledge of the event by phone (210-916-0606), by e-mail (BAMC_IRB_AE@amedd.army.mil), 
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by facsimile (210-916-1650) or via letter addressed to Human Protections Administrator, Office of 
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the Institutional Review Board, Brooke Army Medical Center, Attn: MCHE-CI,3698 Chambers 
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Pass, Fort Sam Houston, TX 78234-6315. A complete written report will follow the initial 
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notification within 10 working days. 
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9.3 Research Monitor.  N/A 
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10.0 WITHDRAWAL FROM STUDY PARTICIPATION.  Subjects may withdraw from the study at any time 
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prior to turning in his/her survey. Their survey packet, if they began to write on it, would be shredded if they 
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withdraw from the study prior to turning it in. Regardless of participating in the study, the patient would still 
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receive the bedside ultrasound as it is part of their clinical care. Because this is an anonymous survey, once 
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the survey is turned in, data will be used and transferred to the Excel Spreadsheet (HUGS DATA 
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TRACKER). There would be no adverse effects for the patient if he or she decided to withdraw from the 
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study. 
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11.0 USAMRMC Volunteer Registry Database. N/A 
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12.0 REFERENCES.   
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1. 1. Cydulka RK, Tamayo-Sarver J, Gage A, and Bagnoli D. Association of patient satisfaction with complaints and risk 
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management among emergency physicians. J Emerg Med. 2011 Oct;41(4):405-11. 
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2. 2. Studdert DM, Mello MM, Sage WM, DesRoches CM, Peugh J, Zapert K, Brennan TA. Defensive medicine among 
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high-risk specialist physicians in a volatile malpractice environment. JAMA. 2005 Jun 1;293(21):2609-17. 
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3. 3. Levin DC, Rao VM, Parker L, and Frangos AJ. Continued growth in emergency department imaging is bucking the 
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overall trends. JACR. 2014 Nov;11(11):1044-7. 
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4. 4. Mettler FA Jr, Huda W, Yoshizumi TT, and Mahesh M. Effective doses in radiology and diagnostic nuclear medicine: 
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a catalog. Radiology. 2008 Jul;248(1):254-63. 
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5. 5. Singer AJ, and Thode HC. Determination of the minimal clinically significant difference on a patient visual analog 
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satisfaction scale. Acad Emerg Med. 1998 Oct;5(10):1007-11. 
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6. 6. Mangelsdorff AD, Finstuen K, Larsen SD, Weinberg EJ. Patient Satisfaction in Military Medicine: Model Refinement 
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and Assessment of Department of Defense Effects 
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13.0 TIME REQUIRED TO COMPLETE THE RESEARCH (including data analysis). Up to 18 months: 12 
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months for recruitment and up to 6 months for analysis and manuscript preparation.  
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14.0 STUDY CLOSURE PROCEDURES:  All paper surveys will be shredded and any computer data with 
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subject numbers will be deleted upon entry into the data collection spreadsheet. After study completion, a final 
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closure report will be submitted to the IRB. Ultimately, a manuscript will be generated with the intent of 
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submitting to a peer-reviewed medical journal for publication. 
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Appendices: 
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Appendix A: Anonymous Subject Survey 
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Appendix B: Provider Survey 
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Appendix C: Subject Information Sheet 
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Appendix D: Email to Emergency Medicine Staff 
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Appendix E: Thermasonic Product Information Sheet 
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Appendix F: ULine Terry Cloth Information Webpage 
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Appendix G: HUGS DataTracker Data Collection Spreadsheet 
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