Anxiety Clinical Trial
Official title:
Effect of Pre-operative Consultation on Patient Anxiety and Satisfaction Following First-time Mohs Micrographic Surgery
NCT number | NCT04612491 |
Other study ID # | 1094298 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | September 6, 2019 |
Est. completion date | March 15, 2024 |
Verified date | June 2023 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Terminated |
Enrollment | 31 |
Est. completion date | March 15, 2024 |
Est. primary completion date | June 3, 2020 |
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) |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Dermatology | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
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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