Impact of Videos on Patient Anxiety and Satisfaction

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Mohs Surgery
• Intervention / Treatment: Behavioral: Pre-Operative Videos; Behavioral: verbal instructions; Behavioral: written 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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-Operative Videos + verbal/written instructions; 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.	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.; Behavioral: 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; Behavioral: 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
Active Comparator: verbal/written instructions; 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	Behavioral: 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; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Jeremy S. Bordeaux, MD, MPH, University Hospitals, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: anxiety; patient satisfaction; skin cancer; video education; linear closure on the face
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: CASE1618

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No