Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-30 @ 10:54 AM
Study NCT ID:
NCT05015569
Status:
UNKNOWN
Last Update Posted:
2022-01-28
First Post:
2021-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare Patients' Perception of Surgical Experience Based on Garment
Sponsor:
More Foundation
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: