Clinical trial NCT06274775: Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction
Official title: Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction: a Single Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Literacy
Satisfaction, Patient
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Age less than 18

Primary outcomes:
measure: Anxiety, as measured by the State Trait Anxiety Inventory
timeFrame: Immediately following nail biopsy consultation
measure: Anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale
timeFrame: Immediately following nail biopsy consultation
measure: Need for information, as measured by the Amsterdam Preoperative Anxiety and Information Scale
timeFrame: Immediately following nail biopsy consultation
measure: Health literacy, as measured by 4 domains of The Health Literacy Questionnaire
timeFrame: Immediately following nail biopsy consultation
measure: Patient satisfaction, as measured by a patient satisfaction survey
timeFrame: Immediately following nail biopsy consultation
Secondary outcomes:
measure: Quality of video intervention for intervention participants, as measured by a qualitative feedback survey
timeFrame: Immediately following nail biopsy consultation
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Cornell Medicine, Department of Dermatology
name: Shari R. Lipner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.