NCT03344497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

June 25, 2019

Status Verified

November 1, 2017

Enrollment Period

8 months

First QC Date

November 13, 2017

Last Update Submit

June 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pre-operative anxiety levels assessed via questionnaire

    Preoperative anxiety and information scale will be collected.

    1 day

Study Arms (2)

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

VC (Conventional Consultation/Video) Group

VC (Conventional Consultation/Video) Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona - Banner University Medicine Dermatology

Tucson, Arizona, 85718, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 17, 2017

Study Start

June 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

June 25, 2019

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations