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临床试验/NCT06274775
NCT06274775已完成不适用

Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction: a Single Center Randomized Controlled Trial

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Anxiety, as measured by the State Trait Anxiety Inventory

研究概览

简要总结

The investigators are interested in studying the effect of an animated video depicting a nail biopsy procedure on the anxiety, health literacy, and satisfaction of participants recommended to undergo a nail biopsy procedure. The investigators hypothesize that the animated video will reduce preoperative anxiety, increase health literacy, and increase patient satisfaction in relation to nail biopsy procedures.

研究设计

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

入排标准

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

入选标准

  • •All patients recommended to receive a nail biopsy procedure in our specialty nail clinic.

排除标准

  • •Age less than 18

研究组 & 干预措施

Standard of Care Group

No Intervention

Standard of care only, which includes verbal information about the procedure and pre-operative and post-operative handouts with instructions provided via quick-response (QR) code.

Educational Video Group

Experimental

Group A (intervention group), which will be shown an educational video about the nail biopsy procedure in addition to standard of care, which includes verbal information about the procedure and pre-operative and post-operative handouts with instructions provided via quick-response (QR) code.

干预措施: Educational Video (Other)

结局指标

主要结局

Anxiety, as measured by the State Trait Anxiety Inventory

时间窗: Immediately following nail biopsy consultation

State Trait Anxiety Inventory uses a scale of 1-4 for each question, with 1 being "not at all" and 4 being "very much so." The maximum score is 80, and the minimum score is 20. Scores from 20-37 indicate "no or low anxiety," scores from 38-44 indicate "moderate anxiety," and scores from 45-80 indicate "high anxiety."

Anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale

时间窗: Immediately following nail biopsy consultation

The Amsterdam Preoperative Anxiety and Information Scale uses a Likert scale from 1-5. The questions focus on anxiety and the need for information, creating two separate sub-scores. This measure assesses the anxiety sub-score, which ranges from 4 to 20 (4 questions) A higher anxiety sub-score indicates a higher anxiety level.

Need for information, as measured by the Amsterdam Preoperative Anxiety and Information Scale

时间窗: Immediately following nail biopsy consultation

The Amsterdam Preoperative Anxiety and Information Scale uses a Likert scale from 1-5. The questions focus on anxiety and the need for information, creating two separate sub-scores. This measure assesses the need for information sub-score, which ranges from 2 to 10 (2 questions). A higher need for information sub-score indicates a higher information requirement.

Patient satisfaction, as measured by a patient satisfaction survey

时间窗: Immediately following nail biopsy consultation

The patient satisfaction survey uses a scale from "not at all" (equivalent to 1 on a Likert scale) to "very much" (equivalent to 4 on a Likert scale), or from "not acceptable" (equivalent to 1 on a Likert scale) to "Acceptable" (equivalent to 3 on a Likert scale). The maximum score is 27, the minimum score is 7, with a higher score indicating higher satisfaction, and a lower score indicating lower satisfaction.

Health literacy, as measured by 4 domains of The Health Literacy Questionnaire

时间窗: Immediately following nail biopsy consultation

Using 4 domains of the The Health Literacy Questionnaire, subjects will respond using a scale from "strongly disagree" (equivalent to 1 point on Likert scale) to "strongly agree" (equivalent to 4 points on Likert scale) or from "cannot do or always difficult" (equivalent to 1 point on Likert scale) to "always easy" (equivalent to 5 points on Likert scale). The maximum score is 86, the minimum score is 19. A higher score indicates higher health literacy, while a lower score indicates lower health literacy.

次要结局

  • Quality of video intervention for intervention participants, as measured by a qualitative feedback survey(Immediately following nail biopsy consultation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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