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Educational Materials for Anxiety During Mohs Surgery

N/A
Waitlist Available
Led By Steven Feldman, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80
Any patient undergoing Mohs micrographic surgery for cutaneous cancer, soft tissue tumors, and adnexal tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 minutes
Awards & highlights

Study Summary

This trial will study anxiety in patients during Mohs surgery, comparing those who have undergone the surgery before to those who have not, as well as those who have read a vignette about the experience to those who have not.

Who is the study for?
This trial is for English-speaking adults aged 18-80 who are undergoing Mohs micrographic surgery for skin cancer or related tumors. It's not suitable for those unable to complete surveys, read a pamphlet about patient experiences, or have it read to them.Check my eligibility
What is being tested?
The study aims to measure anxiety levels in patients during Mohs surgery. It compares first-time patients' anxiety with those returning for another surgery and examines if reading a vignette (a short description of typical experiences) affects their anxiety.See study design
What are the potential side effects?
Since this trial involves educational materials rather than medical treatments, there are no direct side effects from interventions like drugs or surgeries. However, participants may experience varying levels of anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I am having Mohs surgery for skin or soft tissue cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survey to identify factors that modify anxiety - Negative statements
Survey to identify factors that modify anxiety - Positive statements
Visual Analog Scale Scores
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Previous Experience InterventionExperimental Treatment2 Interventions
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.
Group II: First Time InterventionExperimental Treatment2 Interventions
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.
Group III: Previous Experience ControlActive Control1 Intervention
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.
Group IV: First Time ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,250 Previous Clinical Trials
1,007,078 Total Patients Enrolled
21 Trials studying Anxiety
9,032 Patients Enrolled for Anxiety
Steven Feldman, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

Vignette Clinical Trial Eligibility Overview. Trial Name: NCT03756792 — N/A
Anxiety Research Study Groups: Previous Experience Intervention, Previous Experience Control, First Time Control, First Time Intervention
Anxiety Clinical Trial 2023: Vignette Highlights & Side Effects. Trial Name: NCT03756792 — N/A
Vignette 2023 Treatment Timeline for Medical Study. Trial Name: NCT03756792 — N/A
~7 spots leftby Dec 2024
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