Compare Patients' Perception of Surgical Experience Based on Garment

Anxiety Clinical Trial

Official title:

A Randomized, Single-Blinded, Continuous Case Series Study to Examine the Impact of Surgical Garment Selection on Patients' Perception of Their Surgical Experience

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05015569
• Other study ID #: COVR202011092.3
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2021
• Source: More Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	The CORE Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
More Foundation

Country where clinical trial is conducted

United States, 

Outcome

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