AnxietyNCT03756792
Assessing Patient Anxiety During Mohs Micrographic Surgery
A study testing Normal Education Material and Vignette in people with Anxiety, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Normal Education Material and Vignette
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2019to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Normal Education Material, Vignette
- Keywords
- Mohs Micographic Surgery, skin cancer, melanoma
- Medical subject headings
- Anxiety Disorders, Skin Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Education MaterialBehavioural
Patients will receive standard educational material about Mohs micrographic surgery.
VignetteBehavioural
Patients will receive standard educational material about Mohs micrographic surgery and read a vignette detailing the typical experience of a Mohs patient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Normal Education Material; Behavioral: Vignette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start26 Feb 2019
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Feldman, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756792
- Sponsor's protocol ID
- IRB00054156
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2018
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25928283Dubas 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.
PubMed 23369588Kamangar 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.
PubMed 28537871Persichetti 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.
PubMed 19215268Vachiramon 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.
PubMed 23346989Newsom 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.
PubMed 29642110Hawkins 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.
PubMed 29406486Zhang 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.
PubMed 29518455Locke 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.
PubMed 26355630
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient Anxiety During Mohs Micrographic Surgery
- ClinicalTrials.gov ID
- NCT03756792
- Acronym / sponsor ID
- IRB00054156
- Conditions
- Anxiety
- Keywords
- Mohs Micographic Surgery, skin cancer, melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First Time Control | Active comparator | Behavioral: Normal Education MaterialPatients 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. |
| First Time Intervention | Experimental | Behavioral: Normal Education Material, Behavioral: VignettePatients 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. |
| Previous Experience Control | Active comparator | Behavioral: Normal Education MaterialPatients 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. |
| Previous Experience Intervention | Experimental | Behavioral: Normal Education Material, Behavioral: VignettePatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Education MaterialPatients will receive standard educational material about Mohs micrographic surgery. | Behavioural | First Time Control, First Time Intervention, Previous Experience Control, Previous Experience Intervention |
| VignettePatients will receive standard educational material about Mohs micrographic surgery and read a vignette detailing the typical experience of a Mohs patient. | Behavioural | First Time Intervention, Previous Experience Intervention |
Primary outcome
Visual Analog Scale for Anxiety Scores
Time frame: up to 10 minutes
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
Time frame: up to 10 minutes
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
Time frame: up to 10 minutes
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
Time frame: up to 10 minutes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Background: PubMed 25928283Rogers 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.
- Background: PubMed 23369588Dubas 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.
- Background: PubMed 28537871Kamangar 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.
- Background: PubMed 19215268Persichetti 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.
- Background: PubMed 23346989Vachiramon 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.
- Background: PubMed 29642110Newsom 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.
- Background: PubMed 29406486Hawkins 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.
- Background: PubMed 29518455Zhang 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.
- Background: PubMed 26355630Locke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Feldman, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Education Material and Vignette in people with Anxiety, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Anxiety Scores (time frame: up to 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03756792, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.