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Compare Patients' Perception of Surgical Experience Based on Garment

Primary Purpose

Anxiety, Orthopedic Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVR Medical Garment
Standard Patient Gown
Sponsored by
More Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, modesty, dignity, satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The CORE Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patient Gown + COVR garment

Patient Gown

Arm 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.

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

Outcomes

Primary Outcome Measures

Overall perception of anxiety, modesty, privacy, and satisfaction
7 question surveys designed for this study
Overall perception of anxiety, modesty, privacy, and satisfaction
7 question surveys designed for this study

Secondary Outcome Measures

Full Information

First Posted
February 2, 2021
Last Updated
January 27, 2022
Sponsor
More Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05015569
Brief Title
Compare Patients' Perception of Surgical Experience Based on Garment
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
More Foundation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Orthopedic Disorder
Keywords
anxiety, modesty, dignity, satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Treatment allocation will be determined using a block randomized crossover trial design.
Masking
Participant
Masking Description
Patients will be blinded to the difference between garment groups.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Gown + COVR garment
Arm Type
Active Comparator
Arm 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.
Arm Title
Patient Gown
Arm Type
Active Comparator
Arm Description
Patient will receive the standard of care patient gown only without undergarments.
Intervention Type
Device
Intervention Name(s)
COVR Medical Garment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Patient Gown
Intervention Description
The standard patient gown is provided to all patients in a hospital setting.
Primary Outcome Measure Information:
Title
Overall perception of anxiety, modesty, privacy, and satisfaction
Description
7 question surveys designed for this study
Time Frame
Within 2 hours before surgery
Title
Overall perception of anxiety, modesty, privacy, and satisfaction
Description
7 question surveys designed for this study
Time Frame
Up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Jacofsky, PhD
Organizational Affiliation
More Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
The CORE Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared.

Learn more about this trial

Compare Patients' Perception of Surgical Experience Based on Garment

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