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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04612491
Other study ID # 1094298
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 6, 2019
Est. completion date January 2024

Study information

Verified date June 2023
Source University of California, Davis
Contact Angela Calaguas
Phone 9165512636
Email accalaguas@ucdavis.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Pre-operative Consultation
Pre-operative consultation will be given before Mohs surgery

Locations

Country Name City State
United States UC Davis Dermatology Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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