Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery

Terminated

• Conditions: Anxiety; Surgery
• Interventions: Behavioral: Pre-operative Consultation

• Registration Number: NCT04612491
• Lead Sponsor: University of California, Davis

Brief Summary

To determine if in-office pre-operative consultation has a significant effect on the anxiety level and overall post-operative satisfaction of patients undergoing first time Mohs surgery

Detailed Description

This study is designed to determine if having a seperate in-office pre-operative consultation with the dermatologist before having a dermatologic procedure has any effect on patient anxiety levels and satisfaction following the procedure. The goal of the study is to help us understand if pre-operative consultation is beneficial to patients to reduce anxiety and increase satisfaction following the procedure.

Study Timeline

• Study Start: 2019-09-06
• Primary Completion: 2020-06-03
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-03
• Status Verified: 2023-06
• Study Completion: 2024-03-15
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Adults 18 years old or older

  • Able to provide consent for participation
  • Fluency in English
  • Presenting for first-time Mohs surgery for treatment of a cutaneous malignancy

Exclusion Criteria

• • Patients under 18 years old

  • Prisoners
  • Patients unable to provide consent
  • History of prior Mohs surgery
  • Patients requiring multi-disciplinary care (i.e. Involvement of other surgical specialties such as Plastic Surgery or Ophthalmology for reconstruction)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-operative Consultation	Pre-operative Consultation	-

Primary Outcome Measures

Name	Time	Method
The score on the PSQ-18 survey following the Mohs procedure	2 years	The PSQ-18 (aka patient satisfaction questionaire-18) is a validated assessment tool developed to measure holistic patient satisfaction with the aspects of clinical care (assessing six domains of patient satisfaction: technical quality, interpersonal manner, communication, financial aspects of care, accessibility of care and time spent with the physician), and by virtue of its brevity (18 questions taking an average of 3-4 minutes to complete) has great utility for measuring patient satisfaction in the clinical setting. Each question ranges from 1-5. Lower scores are better.; The primary null hypothesis for this study is that mean PSQ-18 survey scores do not differ between patients receiving pre-operative consultation versus those not receiving this intervention.

Secondary Outcome Measures

Name	Time	Method
Patient anxiety as measured on the 10-point VAS scale for anxiety	2 years	The VAS is a horizontal line with a scale ranging from "no anxiety at all" to "extremely anxious." By measuring the position of the patient's response on the line, a score out of 10 will be generated. The VAS for anxiety will be administered to enrolled patients at three time points: randomization (consent visit), pre-operatively on day of Mohs surgery and post-operatively on the day of the Mohs surgical procedure.

Trial Locations

Locations (1)

UC Davis Dermatology; 🇺🇸 Sacramento, California, United States