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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04612491
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
Daniel Eisen, MD, University of California, Davis

Study Description
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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

Condition or disease Intervention/treatment
Anxiety Surgery 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 Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Pre-operative Consultation on Patient Anxiety and Satisfaction Following First-time Mohs Micrographic Surgery
Actual Study Start Date : September 6, 2019
Estimated Primary Completion Date : September 6, 2022
Estimated Study Completion Date : September 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pre-operative Consultation Behavioral: Pre-operative Consultation
Pre-operative consultation will be given before Mohs surgery
No consultation


Outcome Measures
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Primary Outcome Measures :
  1. The score on the PSQ-18 survey following the Mohs procedure [ Time Frame: 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 :
  1. Patient anxiety as measured on the 10-point VAS scale for anxiety [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612491


Contacts
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Contact: Iryna Rybak 9165512636 irybak@ucdavis.edu

Locations
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United States, California
UC Davis Dermatology Recruiting
Sacramento, California, United States, 95816
Contact: Iryna Rybak    916-551-2636    irybak@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
More Information
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Responsible Party: Daniel Eisen, MD, Professor of Clinical Dermatology, Director of Dermatologic Surgery, University of California, Davis
ClinicalTrials.gov Identifier: NCT04612491    
Other Study ID Numbers: 1094298
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders