AnxietyNCT05015569
Compare Patients' Perception of Surgical Experience Based on Garment
A study testing COVR Medical Garment and Standard Patient Gown in people with Anxiety and Orthopedic Disorder, run by More Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Orthopedic Disorder
- What is being tested?
- COVR Medical Garment and Standard Patient Gown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anxiety, Orthopedic Disorder
- Being tested
- COVR Medical Garment, Standard Patient Gown
- Keywords
- anxiety, modesty, dignity, satisfaction
- Medical subject headings
- Anxiety Disorders, Musculoskeletal Diseases, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVR Medical GarmentDevice
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.
Standard Patient GownOther
The standard patient gown is provided to all patients in a hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: COVR Medical Garment; Other: Standard Patient Gown |
| Patient Gown | Active comparator | Patient will receive the standard of care patient gown only without undergarments. Receives: Other: Standard Patient Gown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall perception of anxiety, modesty, privacy, and satisfaction
7 question surveys designed for this study
Measured: Within 2 hours before surgery
Overall perception of anxiety, modesty, privacy, and satisfaction
7 question surveys designed for this study
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start11 Jan 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Treatment allocation will be determined using a block randomized crossover trial design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- More Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Jacofsky, PhD, Principal investigator, More Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015569
- Sponsor's protocol ID
- COVR202011092.3
- Status last verified
- Aug 2021
- First submitted
- 2 Feb 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05015569
- Acronym / sponsor ID
- COVR202011092.3
- Conditions
- Anxiety, Orthopedic Disorder
- Keywords
- anxiety, modesty, dignity, satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- More FoundationUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Treatment allocation will be determined using a block randomized crossover trial design.
| Arm | Type | Receives |
|---|---|---|
| Patient Gown + COVR garment | Active comparator | Device: COVR Medical Garment, Other: Standard Patient GownPatients 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 Gown | Active comparator | Other: Standard Patient GownPatient will receive the standard of care patient gown only without undergarments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVR Medical GarmentCOVR 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. | Device | Patient Gown + COVR garment |
| Standard Patient GownThe standard patient gown is provided to all patients in a hospital setting. | Other | Patient Gown, Patient Gown + COVR garment |
Primary outcome
Overall perception of anxiety, modesty, privacy, and satisfaction
Time frame: Within 2 hours before surgery
7 question surveys designed for this study
Overall perception of anxiety, modesty, privacy, and satisfaction
Time frame: Up to 1 week
7 question surveys designed for this study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Jacofsky, PhD principal investigator
More Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVR Medical Garment and Standard Patient Gown in people with Anxiety and Orthopedic Disorder, run by More Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall perception of anxiety, modesty, privacy, and satisfaction (time frame: Within 2 hours before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.