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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Anxiety; Orthopedic Disorder
• Intervention / Treatment: Device: COVR Medical Garment; Other: Standard Patient Gown

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • The CORE Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient Gown + COVR 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.	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.
Active Comparator: Patient Gown; Patient will receive the standard of care patient gown only without undergarments.	Other: Standard Patient Gown; The standard patient gown is provided to all patients in a hospital setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall perception of anxiety, modesty, privacy, and satisfaction	7 question surveys designed for this study	Within 2 hours before surgery
Overall perception of anxiety, modesty, privacy, and satisfaction	7 question surveys designed for this study	Up to 1 week

Collaborators and Investigators

• Sponsor: More Foundation
• Investigators: Principal Investigator: Marc Jacofsky, PhD, MoRe Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: satisfaction; anxiety; dignity; modesty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: COVR202011092.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes