Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06274775
• Other study ID #: 23-12026811
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Shari R. Lipner, MD, PhD
• Phone: (646) 962-3376
• Email: shl9032[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age less than 18

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Literacy
• Satisfaction, Patient

Intervention

Other:
• Educational Video
Educational video about the nail biopsy procedure

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hou H, Li X, Song Y, Ji Y, Sun M, Wang D, Jiao J, Qu J, Gu H. Effect of interactive, multimedia-based home-initiated education on preoperative anxiety inchildren and their parents: a single-center randomized controlled trial. BMC Anesthesiol. 2023 Mar 28;23(1):95. doi: 10.1186/s12871-023-02055-7. — View Citation

Lee DK, Chang MJ, Desai AD, Lipner SR. Clinical and dermoscopic findings of benign longitudinal melanonychia due to melanocytic activation differ by skin type and predict likelihood of nail matrix biopsy. J Am Acad Dermatol. 2022 Oct;87(4):792-799. doi: 10.1016/j.jaad.2022.06.1165. Epub 2022 Jun 22. — View Citation

Turkdogan S, Roy CF, Chartier G, Payne R, Mlynarek A, Forest VI, Hier M. Effect of Perioperative Patient Education via Animated Videos in Patients Undergoing Head and Neck Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Feb 1;148(2):173-179. doi: 10.1001/jamaoto.2021.3765. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety, as measured by the State Trait Anxiety Inventory	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."	Immediately following nail biopsy consultation
Primary	Anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale	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.	Immediately following nail biopsy consultation
Primary	Need for information, as measured by the Amsterdam Preoperative Anxiety and Information Scale	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.	Immediately following nail biopsy consultation
Primary	Health literacy, as measured by 4 domains of The Health Literacy Questionnaire	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.	Immediately following nail biopsy consultation
Primary	Patient satisfaction, as measured by a patient satisfaction survey	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.	Immediately following nail biopsy consultation
Secondary	Quality of video intervention for intervention participants, as measured by a qualitative feedback survey	The qualitative survey focuses on themes of interest, understandability, video length, and whether 2D animation is an effective method to convey medical information.	Immediately following nail biopsy consultation