NCT05015569

Compare Patients' Perception of Surgical Experience Based on Garment

A Randomized, Single-Blinded, Continuous Case Series Study to Examine the Impact of Surgical Garment Selection on Patients' Perception of Their Surgical Experience

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: More Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to compare how patients rank perception of anxiety, modesty, dignity and overall satisfaction when patients are provided with either a standard patient gown or a standard patient gown plus a pair of specialized surgical undergarments (COVR Medical) for orthopedic surgical procedures.

Detailed description

Given the movement in patient modesty, and the limited number of studies focused specifically on how preserving patient modesty/privacy impacts the patient's perception of the hospital experience, targeted studies with larger sample sizes are clearly needed to better understand these complex interactions. This study seeks to compare how patients rank perception of anxiety, modesty, dignity and overall satisfaction when patients are provided with either a standard patient gown or a standard patient gown plus specialized surgical undergarments (COVR Medical) for orthopedic surgical procedures. The investigators hypothesize that the group with the standard patient gown plus a specialized surgical undergarment will have lower anxiety and increased perception of modesty, dignity, and satisfaction. A secondary objective is to determine whether there is a difference in treatment surgical subgroups regarding anxiety, modesty, dignity, and overall satisfaction.

Conditions

• Anxiety
• Orthopedic Disorder

Interventions

Type	Name	Description
DEVICE	COVR Medical Garment	COVR undergarments are available in a "Half Short" design for unilateral lower extremity procedures and a "Bilateral" (brief) style garment designed for bilateral lower extremity procedures. Either style may be worn for upper extremity, trunk, spine procedures, etc. where an undergarment would be preferred along with a standard hospital gown. The garments are available in a variety of sizes. The COVR garments can be released at the hip(s)/waistline for improved access to the lateral hip and include retractable panels for procedural access to the groin and genitals if needed by the care team.
OTHER	Standard Patient Gown	The standard patient gown is provided to all patients in a hospital setting.

Timeline

• Start date: 2021-01-11
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-08-20
• Last updated: 2022-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study