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

Effect of Pre-operative Consultation on Patient Anxiety and Satisfaction Following First-time Mohs Micrographic Surgery

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

Study Overview

• Status: Terminated
• Conditions: Anxiety; Surgery
• Intervention / Treatment: Behavioral: Pre-operative Consultation

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 Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • UC Davis Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients at r the UC Davis Dermatology Clinic who are scheduled for the Mohs procedure.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-operative Consultation	Behavioral: Pre-operative Consultation; Pre-operative consultation will be given before Mohs surgery
No consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score on the PSQ-18 survey following the Mohs procedure	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient anxiety as measured on the 10-point VAS scale for anxiety	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.	2 years

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2019
• Primary Completion (Actual): June 3, 2020
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 1094298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No