Animated Video Consultation for Reducing Pre-Operative An... | NCT03344497

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

NCT03344497

Sponsor

University of Arizona

Status

Completed

Last Update Posted

Jun 25, 2019Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Dermatology/Skin - Other

Interventions

VC Group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Feb 1, 2018Actual

Completion Date

Feb 1, 2018Actual

First Submitted Date

Nov 13, 2017

First Submission Date that Met QC Criteria

Nov 13, 2017

First Posted Date

Nov 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2019

Last Update Posted Date

Jun 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VC Group	Other	VC (Conventional Consultation/Video) Group	VC (Conventional Consultation/Video) Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona - Banner University Medicine Dermatology		Tucson	Arizona	85718	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided