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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03485937
Other study ID # CASE1618
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date July 2019

Study information

Verified date October 2019
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to look at how educational videos might affect patient satisfaction and anxiety before Mohs surgery day. Patients will be randomized to either: 1) a group that receives educational videos before the visit in addition to standard-of-care written and verbal instructions OR 2) a group that receives only standard-of-care written and verbal instructions.


Description:

The primary objective of this study is to determine if pre-operative videos describing the patient's forthcoming day in the Mohs clinic decrease pre-operative patient anxiety and increase postoperative patient satisfaction, when added to standard of care written and verbal instruction.

Design/Study Type This study will be a randomized control trial in which patients will be randomized to either the intervention (pre-operative Mohs Surgery video viewing) or control (standard of care) group in order to understand the impact of the video on patient anxiety and satisfaction. Patients will be randomized using an Accelerated Biased Coin Design in the statistical program R.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who are at the University Hospitals Cleveland Medical Center Mohs Clinic to undergo a linear closure on the face.

- Fluent English speakers

Exclusion Criteria:

- Non-fluent English speakers

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Pre-Operative Videos
Videos will be created by the study team to ensure that the content coincides with what is delivered in the standard-of-care verbal and written instructions. The videos will be split into two modules: 1) preparing for Mohs Surgery 2) Mohs Surgery Walk through. The intervention, in the form of a video walk through, will be provided to the patient via email prior to their surgical procedure once they schedule an appointment with the Mohs clinic for their surgery day.
verbal instructions
As part of the standard of care for patients receiving Mohs surgery, patients are told about the day of their surgery and what to expect
written instructions
As part of the standard of care for patients receiving Mohs surgery, patients receive written material about the day of their surgery and what to expect

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in mean Likert scale rating of subject satisfaction score For subject satisfaction score, the mean Likert scale rating for the control and intervention groups will be compared. The scale being used is a six item instrument with individual scores ranging from 1-5 (total score 6-30). Higher scores indicate greater satisfaction. Up to 8 weeks after visit
Primary Difference in mean Likert scale rating of subject anxiety score For subject anxiety score, the mean Likert scale rating for the control and intervention groups will be compared. The scale being used is a seven item instrument with individual scores ranging from 1-5 with positive worded items scored in reverse (total score 7-35). Higher scores indicate greater anxiety Up to 8 weeks after visit
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