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Completed

NCT Number: NCT06274775

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age less than 18

Treatment and study plan

Educational Video

Other

Educational video about the nail biopsy procedure

Primary outcomes

  1. Anxiety, as measured by the State Trait Anxiety Inventory

    Time frame: 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."

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Patient satisfaction, as measured by a patient satisfaction survey

    Time frame: 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.

Secondary outcomes

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

    Time frame: Immediately following nail biopsy consultation

    The qualitative survey focuses on themes of interest, understandability, video length, and whether 2D animation is an effective method to convey medical information.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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