Educational Materials for Anxiety During Mohs Surgery

Overseen By Irma M Richardson, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 18, Over 80, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Normal Education Material, Vignette for reducing anxiety during Mohs Surgery?

Research suggests that providing patients with educational materials and information about what to expect during Mohs surgery can help reduce anxiety. Specifically, patients who received calls discussing their diagnosis and read written materials reported decreased anxiety, indicating that education and information can be effective in calming patients before surgery. ^{1 2 3 4 5}

Is it safe to use educational materials to reduce anxiety during Mohs surgery?

There is no specific safety data on using educational materials for anxiety during Mohs surgery, but providing information and engaging in comforting activities can help reduce anxiety without the need for medication. ^{1 2 4 6 7}

How does the treatment of educational materials for anxiety during Mohs surgery differ from other treatments?

This treatment is unique because it focuses on providing educational materials to help reduce anxiety, which is different from other treatments like music therapy or pharmacologic interventions. It aims to inform patients about the procedure, potentially reducing anxiety by increasing understanding and setting expectations. ^{1 4 8 9 10}

What is the purpose of this trial?

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.

Research Team

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

Inclusion Criteria

Subjects with a working knowledge of English

I am having Mohs surgery for skin or soft tissue cancer.

Exclusion Criteria

I am able to complete surveys and read or listen to pamphlets.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive normal education material and may read a vignette about the typical experience of a Mohs patient, followed by a survey

1 day

1 visit (in-person)

Follow-up

Participants are monitored for anxiety levels using surveys and visual analog scales

up to 10 minutes

Treatment Details

Interventions

• Normal Education Material
• Vignette

Trial Overview 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.

Participant Groups

Group I: Previous Experience Intervention Experimental Treatment 2 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 Intervention Experimental Treatment 2 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 Control Active Control 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

2015 Arte Poster Competition First Place Winner: Assessing the Correlation Between Patient Anxiety and Satisfaction for Mohs Surgery. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

The use of 3-dimensionally printed models to optimize patient education and alleviate perioperative anxiety in Mohs micrographic surgery: A randomized controlled trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Preoperative telephone consultation does not decrease patient anxiety before Mohs micrographic surgery. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Anxiety levels of patients undergoing common dermatologic procedures versus those seeking general dermatologic care. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Analysis of Factors Contributing to Perioperative Mohs Micrographic Surgery Anxiety: Patient Survey Study at an Academic Center. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events associated with mohs micrographic surgery: multicenter prospective cohort study of 20,821 cases at 23 centers. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The safety of Mohs surgery: a prospective multicenter cohort study. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Music reduces patient anxiety during Mohs surgery: an open-label randomized controlled trial. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic and Nonpharmacologic Interventions for Perioperative Anxiety in Patients Undergoing Mohs Micrographic Surgery: A Systematic Review. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Perioperative Anxiety Associated With Mohs Micrographic Surgery: A Survey-Based Study. [2023]