Animated Video Consultation for Reducing Pre-Operative Anxiety in Outpatient Dermatologic Surgery

June 24, 2019 updated by: University of Arizona
The purpose of this study is to evaluate whether the addition of an animated skin surgery educational video to conventional in-person surgery consultation will help reduce pre-operative anxiety in patients awaiting outpatient skin surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be an randomized controlled pilot study. Subjects will be randomized to either receive an animated video along with conventional consultation OR receive a conventional consultation only. Pre-operative anxiety will be assessed.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85718
        • University of Arizona - Banner University Medicine Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. Male and female, at least 18 years of age
  2. Subjects scheduled to undergo outpatient skin surgery
  3. Subjects able to comprehend and read the English language.

Exclusion Criteria:

  1. Subjects unable to or unwilling to comply with the study procedures
  2. Subjects unable to speak or read the English language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: VC (Conventional Consultation/Video) Group
Subjects will receive conventional consultation and watch an animated video.
Other: VC Group
VC (Conventional Consultation/Video) Group
No Intervention: CC (Conventional Consultation) Group
Subjects will receive conventional consultation only. Subjects will cross-over to receive animated video at the end.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-operative anxiety levels assessed via questionnaire
Time Frame: 1 day
Preoperative anxiety and information scale will be collected.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1702192435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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