Assessing Patient Anxiety During Mohs Micrographic Surgery

Anxiety Clinical Trial

Official title:

Assessing Patient Anxiety During Mohs Micrographic Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03756792
• Other study ID #: IRB00054156
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

There has been a continual increase in cases of nonmelanoma skin cancer and melanoma over the last several decades. With the increase in incidence, there is also the need for increased treatment. Mohs micrographic surgery (MMS) is highly efficacious, with cure rates in the upper 90% for both basal cell carcinoma and squamous cell carcinoma, the two most common forms of skin cancer. MMS is used for tumors in cosmetically sensitive areas or areas of recurrence.

While MMS is usually performed in the outpatient setting, it may be an anxiety provoking experience for patients, ranging from the fear of a cancer diagnosis, to concerns about the procedural events of the surgery and associated pain, to the anticipation of their final cosmetic result. During a MMS procedure, unlike many other types of surgery or procedures, the patient is awake and aware of his or her surroundings, with periods of waiting interspersed throughout the procedure. Such aspects can lead to the high level of perioperative anxiety in MMS patients. The effects of listening to music, watching preoperative informational videos, and the use of web-based applications have been used to attempt to decrease anxiety in MMS patients. However, causes for differences in anxiety level between first time MMS patients and patients returning for a subsequent MMS procedure are not well characterized.

One approach to reduce patient anxiety involves patient education, where patients are presented statistics about the small likelihood of complication from the MMS procedure. However, patients interpret these data very subjectively. The study team proposes an alternative approach to patient education through patient vignettes. A previous study explored using a narrative video that included patient testimonials, but this video also used patient-physician interaction and drawings. In this study, patients will be provided short vignettes, that would include information about the experience of a typical MMS patient.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Normal Education Material
Patients will receive standard educational material about Mohs micrographic surgery.
• Vignette
Patients will receive standard educational material about Mohs micrographic surgery and read a vignette detailing the typical experience of a Mohs patient.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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