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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 minutes

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,239 Previous Clinical Trials

1,004,083 Total Patients Enrolled

20 Trials studying Anxiety

9,002 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 Control, First Time Control, Previous Experience Intervention, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to those who are over the age of 35?

"According to the trial's criteria, eligible applicants must be between 18 and 80 years of age. There are a total of 147 trials available for minors, while 441 are reserved for those that exceed 65 years old."

Answered by AI

Are any openings still available for the trial participants?

"Clinicaltrials.gov reports that the trial is currently accruing subjects, with its inception in February 2019 and latest update occurring on October 26th 2022."

Answered by AI

How many test subjects are enrolled in this clinical experiment?

"Affirmative. The information presented on clinicaltrials.gov implies that this trial is presently recruiting participants, with an initial posting date of February 26th 2019 and a final update occurring October 26th 2022. This study requires 100 recruits from one medical facility to complete the research objectives."

Answered by AI

What criteria must individuals meet to be eligible for participation in this medical experiment?

"This research seeks to include 100 individuals between 18 and 80 years of age who are suffering from anxiety. To be eligible, applicants must have a functioning command of the English language and any potential participants that require Mohs micrographic surgery for cutaneous cancer, soft tissue tumors, or adnexal tumors may also apply."

Answered by AI