Dermatology/Skin - OtherNCT03344497
Animated Video Consultation for Reducing Pre-Operative Anxiety in Outpatient Dermatologic Surgery
A study testing VC Group in people with Dermatology/Skin - Other, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatology/Skin - Other
- What is being tested?
- VC Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 1 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects unable to or unwilling to comply with the study procedures
- Subjects unable to speak or read the English language.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona - Banner University Medicine Dermatology
Tucson, Arizona, 85718
About this study
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.
Read the 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.
- Conditions
- Dermatology/Skin - Other
- Being tested
- VC Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC GroupOther
VC (Conventional Consultation/Video) Group
| Study group | Role | What they receive |
|---|---|---|
| VC (Conventional Consultation/Video) Group | Other | Subjects will receive conventional consultation and watch an animated video. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative anxiety levels assessed via questionnaire
Preoperative anxiety and information scale will be collected.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jun 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatology/Skin - OtherStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344497
- Sponsor's protocol ID
- 1702192435
- Status last verified
- Nov 2017
- First submitted
- 13 Nov 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animated Video Consultation for Reducing Pre-Operative Anxiety in Outpatient Dermatologic Surgery
- ClinicalTrials.gov ID
- NCT03344497
- Acronym / sponsor ID
- 1702192435
- Conditions
- Dermatology/Skin - Other
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VC (Conventional Consultation/Video) Group | Other | Other: VC GroupSubjects will receive conventional consultation and watch an animated video. |
| CC (Conventional Consultation) Group | No intervention | –Subjects will receive conventional consultation only. Subjects will cross-over to receive animated video at the end. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects unable to or unwilling to comply with the study procedures
- Subjects unable to speak or read the English language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VC GroupVC (Conventional Consultation/Video) Group | Other | VC (Conventional Consultation/Video) Group |
Primary outcome
Pre-operative anxiety levels assessed via questionnaire
Time frame: 1 day
Preoperative anxiety and information scale will be collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Dermatology/Skin - Other
RecruitingObservational study
Cutaneous and Mucosal Manifestations of Neurofribromatosis Type 2 in Children Under 15
Neurofibromatosis 2, Dermatology/Skin - Other
Recruiting
Application of the Belle.AI Dermatological Image Reference System for Patient Diagnosis in an Active Clinical Setting
Skin Condition, Dermatology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VC Group in people with Dermatology/Skin - Other, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative anxiety levels assessed via questionnaire (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.