Compare Patients' Perception of Surgical Experience Based on Garment

Not Applicable

• Conditions: Orthopedic Disorder; Anxiety
• Interventions: Device: COVR Medical Garment; Other: Standard Patient Gown

• Registration Number: NCT05015569
• Lead Sponsor: More Foundation

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.

Study Timeline

• Study Start: 2021-01-11
• Study First Submitted: 2021-02-02
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-20
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patient Gown + COVR garment	Standard Patient Gown	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.
Patient Gown	Standard Patient Gown	Patient will receive the standard of care patient gown only without undergarments.
Patient Gown + COVR garment	COVR Medical Garment	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.

Primary Outcome Measures

Name	Time	Method
Overall perception of anxiety, modesty, privacy, and satisfaction	Up to 1 week	7 question surveys designed for this study

Trial Locations

Locations (1)

The CORE Institute; 🇺🇸 Phoenix, Arizona, United States