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