Clinical trial NCT05015569: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Orthopedic Disorder
Keywords: anxiety
modesty
dignity
satisfaction
Lead sponsor: More Foundation
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Treatment allocation will be determined using a block randomized crossover trial design.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall perception of anxiety, modesty, privacy, and satisfaction
timeFrame: Within 2 hours before surgery
measure: Overall perception of anxiety, modesty, privacy, and satisfaction
timeFrame: Up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The CORE Institute
state: Arizona
Study officials:
affiliation: More Foundation
name: Marc Jacofsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: