Compare Patients' Perception of Surgical Experience Based on Garment

NCT05015569 | Unknown FDA Device

• 1 other identifier: COVR202011092.3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Orthopedic Disorder

Keywords

anxiety; modesty; dignity; satisfaction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Patient Gown + COVR garment

ACTIVE COMPARATOR

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; Other: Standard Patient Gown

Patient Gown

ACTIVE COMPARATOR

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

Other: Standard Patient Gown

Interventions

COVR Medical Garment DEVICE

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.

Patient Gown + COVR garment

Standard Patient Gown OTHER

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

Patient Gown; Patient Gown + COVR garment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• More Foundation: lead

Study Sites (1)

The CORE Institute

Phoenix, Arizona, 85023, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Musculoskeletal Diseases; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Marc Jacofsky, PhD

  More Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to the difference between garment groups.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: August 20, 2021
• Study Start: January 11, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: January 28, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)