Compare Patients' Perception of Surgical Experience Based on Garment

More Foundation

Status: Unknown

Conditions: Orthopedic Disorder; Anxiety

Treatments: Device: COVR Medical Garment; Other: Standard Patient Gown

Study type: Interventional

Funder types: Other

Identifiers

NCT05015569

COVR202011092.3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Patient Gown + COVR garment

Active Comparator group

Description:

Patients will receive the standard of care patient gown and a COVR garment. Patients undergoing unilateral lower extremity surgery will receive a half short. Patients undergoing upper extremity or spine surgery will receive the brief (bilateral) style COVR garment.

Treatment:

Other: Standard Patient Gown

Device: COVR Medical Garment

Patient Gown

Active Comparator group

Description:

Patient will receive the standard of care patient gown only without undergarments.

Treatment:

Other: Standard Patient Gown