Assessing Patient Anxiety During Mohs Micrographic Surgery

NCT03756792 | Completed

• 1 other identifier: IRB00054156
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the anxiety that patients are experiencing during a Mohs micrographic surgery. The study will compare the feelings of anxiety experienced by patients returning for Mohs surgery after already undergoing the surgery at least one time to feelings experienced by patients who have never had Mohs surgery before. The study will also compare the feelings experienced by patients who have read a vignette about the typical Mohs experience to the feelings of patients who have not read a vignette.

Conditions

Anxiety

Keywords

Mohs Micographic Surgery; skin cancer; melanoma

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale for Anxiety Scores

  This outcome will assess the difference in VAS-A scores for patients based on prior experience with MMS versus first-time MMS. A higher score denotes a worse outcome.

  up to 10 minutes

• Visual Analog Scale Scores

  This outcome will assess the difference the difference in VAS-A score between the control and intervention groups that read patient vignettes. A higher score denotes a worse outcome.

  up to 10 minutes

• Survey to identify factors that modify anxiety - Positive statements

  The survey presents 2 statements to be answered each on a 5-point likert scale to assess patients feelings of anxiety in the perioperative period. A higher score denotes a better outcome. Total score 0-10

  up to 10 minutes

• Survey to identify factors that modify anxiety - Negative statements

  The survey presents 2 statements to be answered each on a 5-point likert scale to assess patients feelings of anxiety in the perioperative period. A higher score denotes a worse outcome. Total score 0-10

  up to 10 minutes

Study Arms (4)

First Time Control

ACTIVE COMPARATOR

Patients with no prior experience of Mohs surgery will be randomly assigned to the control group. The control group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology, then fill out a brief survey.

Behavioral: Normal Education Material

First Time Intervention

EXPERIMENTAL

Patients with no prior experience of Mohs surgery will be randomly assigned to the intervention group. The intervention group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology and read a vignette about the typical experience of a Mohs patient, then fill out a brief survey.

Behavioral: Normal Education Material; Behavioral: Vignette

Previous Experience Control

ACTIVE COMPARATOR

Patients with prior experience of Mohs surgery will be randomly assigned to the control group. The control group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology, then fill out a brief survey.

Behavioral: Normal Education Material

Previous Experience Intervention

EXPERIMENTAL

Patients with prior experience of Mohs surgery will be randomly assigned to the intervention group. The intervention group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology and read a vignette about the typical experience of a Mohs patient, then fill out a brief survey.

Behavioral: Normal Education Material; Behavioral: Vignette

Interventions

Vignette BEHAVIORAL

Patients will receive standard educational material about Mohs micrographic surgery and read a vignette detailing the typical experience of a Mohs patient.

First Time Intervention; Previous Experience Intervention

Normal Education Material BEHAVIORAL

Patients will receive standard educational material about Mohs micrographic surgery.

First Time Control; First Time Intervention; Previous Experience Control; Previous Experience Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient undergoing Mohs micrographic surgery for cutaneous cancer, soft tissue tumors, and adnexal tumors
• Subjects with a working knowledge of English
• Age 18-80

You may not qualify if:

• Patients unable to fill out a paper or electronic survey or read a short pamphlet on prior patient experiences, or those unwilling to have either of the previously stated items read aloud to them.
• Individuals less than 18 or greater than 80 years old (line of questioning necessary for the study may be beyond understanding in this group)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (9)

• Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol. 2015 Oct;151(10):1081-6. doi: 10.1001/jamadermatol.2015.1187.

  PMID: 25928283 BACKGROUND

• Dubas LE, Ingraffea A. Nonmelanoma skin cancer. Facial Plast Surg Clin North Am. 2013 Feb;21(1):43-53. doi: 10.1016/j.fsc.2012.10.003.

  PMID: 23369588 BACKGROUND

• Kamangar F, Petukhova TA, Monico G, Mathis S, Joo J, Zhuang A, Li CS, Liu Y, Lee E, Eisen D. Anxiety levels of patients undergoing common dermatologic procedures versus those seeking general dermatologic care. Dermatol Online J. 2017 May 15;23(5):13030/qt64d8r1gq.

  PMID: 28537871 BACKGROUND

• Persichetti GB, Walling HW, Ceilley RI. Personalized music enhances patient perception of the Mohs surgery experience. Dermatol Surg. 2009 Feb;35(2):265-7. doi: 10.1111/j.1524-4725.2008.34422.x. No abstract available.

  PMID: 19215268 BACKGROUND

• Vachiramon V, Sobanko JF, Rattanaumpawan P, Miller CJ. Music reduces patient anxiety during Mohs surgery: an open-label randomized controlled trial. Dermatol Surg. 2013 Feb;39(2):298-305. doi: 10.1111/dsu.12047. Epub 2013 Jan 24.

  PMID: 23346989 BACKGROUND

• Newsom E, Lee E, Rossi A, Dusza S, Nehal K. Modernizing the Mohs Surgery Consultation: Instituting a Video Module for Improved Patient Education and Satisfaction. Dermatol Surg. 2018 Jun;44(6):778-784. doi: 10.1097/DSS.0000000000001473.

  PMID: 29642110 BACKGROUND

• Hawkins SD, Koch SB, Williford PM, Feldman SR, Pearce DJ. Web App- and Text Message-Based Patient Education in Mohs Micrographic Surgery-A Randomized Controlled Trial. Dermatol Surg. 2018 Jul;44(7):924-932. doi: 10.1097/DSS.0000000000001489.

  PMID: 29406486 BACKGROUND

• Zhang J, Miller CJ, O'Malley V, Etzkorn JR, Shin TM, Sobanko JF. Patient quality of life fluctuates before and after Mohs micrographic surgery: A longitudinal assessment of the patient experience. J Am Acad Dermatol. 2018 Jun;78(6):1060-1067. doi: 10.1016/j.jaad.2018.02.065. Epub 2018 Mar 5.

  PMID: 29518455 BACKGROUND

• Locke MC, Wilkerson EC, Mistur RL, Nisar M, Love WE. 2015 Arte Poster Competition First Place Winner: Assessing the Correlation Between Patient Anxiety and Satisfaction for Mohs Surgery. J Drugs Dermatol. 2015 Sep;14(9):1070-2.

  PMID: 26355630 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Skin Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas

Study Officials

• Steven Feldman, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 28, 2018
• Study Start: February 26, 2019
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: January 29, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)