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

NCT06274775 | Recruiting

• 1 other identifier: 23-12026811
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Literacy; Satisfaction, Patient

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Quality of video intervention for intervention participants, as measured by a qualitative feedback survey

  Immediately following nail biopsy consultation

Study Arms (2)

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.

Other: Educational Video

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.

Interventions

Educational Video OTHER

Educational video about the nail biopsy procedure

Educational Video Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age less than 18

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 35752275 BACKGROUND

• 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.

  PMID: 34967863 BACKGROUND

• 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.

  PMID: 36977985 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Literacy; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Communication; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Shari R. Lipner, MD, PhD

  Weill Cornell Medicine, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shari R. Lipner, MD, PhD

CONTACT

(646) 962-3376; shl9032@med.cornell.edu

Rachel C Hill, BS

CONTACT

(502) 417-0984; rch4001@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 23, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)