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临床试验/NCT05015569
NCT05015569Unknown不适用

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

More Foundation1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Overall perception of anxiety, modesty, privacy, and satisfaction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients will be blinded to the difference between garment groups.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: COVR Medical Garment (Device)

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.

干预措施: Standard Patient Gown (Other)

Patient Gown

Active Comparator

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

干预措施: Standard Patient Gown (Other)

结局指标

主要结局

Overall perception of anxiety, modesty, privacy, and satisfaction

时间窗: Up to 1 week

7 question surveys designed for this study

Overall perception of anxiety, modesty, privacy, and satisfaction

时间窗: Within 2 hours before surgery

7 question surveys designed for this study

次要结局

未报告次要终点

研究者

发起方
More Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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