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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05015569
Enrollment
200
Registered
2021-08-20
Start date
2021-01-11
Completion date
2022-02-28
Last updated
2022-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Orthopedic Disorder

Keywords

anxiety, modesty, dignity, satisfaction

Brief 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.

Interventions

DEVICECOVR 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.

OTHERStandard Patient Gown

The standard patient gown is provided to all patients in a hospital setting.

Sponsors

More Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Patients will be blinded to the difference between garment groups.

Intervention model description

Treatment allocation will be determined using a block randomized crossover trial design.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled to undergo surgery by a musculoskeletal surgeon at The CORE Institute orthopedic Specialty Hospital (CISH). * Adults 18 years or older. * Will receive orthopedic surgery of the lower extremity, upper extremity or spine. * Speaks, reads, and understands English * Enrolled pre-operatively within 3 weeks of surgery date.

Exclusion criteria

* Unwilling to provide informed consent. * Unwilling to participate in surveys. * Body habitus outside of the COVR medical size range. (See Appendix 1) * Procedure that does not meet the medical billing and coding definition of Surgery. * Incarcerated.

Design outcomes

Primary

MeasureTime frameDescription
Overall perception of anxiety, modesty, privacy, and satisfactionWithin 2 hours before surgery7 question surveys designed for this study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026