Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel (HUGS)
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|ClinicalTrials.gov Identifier: NCT03135379|
Recruitment Status : Completed
First Posted : May 1, 2017
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ultrasound||Device: Heated ultrasound gel Device: Room temperature gel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||A heat-resistant glove, ULine Terry Cloth Glove (Appendix F), will be used by the investigators to handle the ultrasound gels.|
|Official Title:||Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel: a Single-blind Randomized Controlled Trial|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Experimental: Heated gel
Patient undergoes ultrasound study using the intervention of heated ultrasound gel.
Device: Heated ultrasound gel
Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit).
Placebo Comparator: Room temperature gel
Patient undergoes ultrasound study using the intervention of room temperature gel.
Device: Room temperature gel
Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off.
- Patient Satisfaction [ Time Frame: Immediately upon completion of ultrasound examination ]Measured on 100-mm visual analogue scale. This scale is a horizontal line on a sheet of paper measuring 100 mm. The scale ranges from 0 on the left (representing "completely unsatisfied") to 100 on the right (representing "completely satisfied"). We instructed subjects to draw a single vertical mark through the horizontal line to represent how satisfied they were with their overall emergency department visit.
- Ultrasound Image Quality [ Time Frame: Within 1 week of completion of ultrasound examination ]Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135379
|Principal Investigator:||Benjamin M Krainin, MDfirstname.lastname@example.org|