search
Back to results

Assessing Patient Anxiety During Mohs Micrographic Surgery

Primary Purpose

Anxiety

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normal Education Material
Vignette
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety focused on measuring Mohs Micographic Surgery, skin cancer, melanoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Wake Forest Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

First Time Control

First Time Intervention

Previous Experience Control

Previous Experience Intervention

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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
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

Secondary Outcome Measures

Full Information

First Posted
November 27, 2018
Last Updated
August 28, 2023
Sponsor
Wake Forest University Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03756792
Brief Title
Assessing Patient Anxiety During Mohs Micrographic Surgery
Official Title
Assessing Patient Anxiety During Mohs Micrographic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Mohs Micographic Surgery, skin cancer, melanoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First Time Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
First Time Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Previous Experience Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Previous Experience Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Normal Education Material
Intervention Description
Patients will receive standard educational material about Mohs micrographic surgery.
Intervention Type
Behavioral
Intervention Name(s)
Vignette
Intervention Description
Patients will receive standard educational material about Mohs micrographic surgery and read a vignette detailing the typical experience of a Mohs patient.
Primary Outcome Measure Information:
Title
Visual Analog Scale for Anxiety Scores
Description
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.
Time Frame
up to 10 minutes
Title
Visual Analog Scale Scores
Description
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.
Time Frame
up to 10 minutes
Title
Survey to identify factors that modify anxiety - Positive statements
Description
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
Time Frame
up to 10 minutes
Title
Survey to identify factors that modify anxiety - Negative statements
Description
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
Time Frame
up to 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Feldman, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25928283
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.
Results Reference
background
PubMed Identifier
23369588
Citation
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.
Results Reference
background
PubMed Identifier
28537871
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.
Results Reference
background
PubMed Identifier
19215268
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.
Results Reference
background
PubMed Identifier
23346989
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.
Results Reference
background
PubMed Identifier
29642110
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.
Results Reference
background
PubMed Identifier
29406486
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.
Results Reference
background
PubMed Identifier
29518455
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.
Results Reference
background
PubMed Identifier
26355630
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.
Results Reference
background

Learn more about this trial

Assessing Patient Anxiety During Mohs Micrographic Surgery

We'll reach out to this number within 24 hrs