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Clinical Trials/NCT03485937
NCT03485937WithdrawnNot Applicable

Impact of Pre-Operative Videos on Mohs Surgery Patient Anxiety and Satisfaction

Case Comprehensive Cancer Center0 sitesStarted: June 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Difference in mean Likert scale rating of subject satisfaction score

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Pre-Operative Videos + verbal/written instructions

Experimental

This video contains the same instructions that the patient receives when they arrive at the clinic, as well as a video walk through of the clinic/patient room. 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.

Intervention: Pre-Operative Videos (Behavioral)

Pre-Operative Videos + verbal/written instructions

Experimental

This video contains the same instructions that the patient receives when they arrive at the clinic, as well as a video walk through of the clinic/patient room. 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.

Intervention: verbal instructions (Behavioral)

Pre-Operative Videos + verbal/written instructions

Experimental

This video contains the same instructions that the patient receives when they arrive at the clinic, as well as a video walk through of the clinic/patient room. 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.

Intervention: written instructions (Behavioral)

verbal/written instructions

Active Comparator

This arm will receive the standard-of-care verbal/written instructions and the pre-operative video explanation. These instructions contain the same content as in the pre-operative videos

Intervention: verbal instructions (Behavioral)

verbal/written instructions

Active Comparator

This arm will receive the standard-of-care verbal/written instructions and the pre-operative video explanation. These instructions contain the same content as in the pre-operative videos

Intervention: written instructions (Behavioral)

Outcomes

Primary Outcomes

Difference in mean Likert scale rating of subject satisfaction score

Time Frame: Up to 8 weeks after visit

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.

Difference in mean Likert scale rating of subject anxiety score

Time Frame: Up to 8 weeks after visit

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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