Mohs SurgeryNCT03485937
Impact of Videos on Patient Anxiety and Satisfaction
A study testing Pre-Operative Videos, verbal instructions and written instructions in people with Mohs Surgery, run by Case Comprehensive Cancer Center.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mohs Surgery
- What is being tested?
- Pre-Operative Videos, verbal instructions and written instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to Jul 2019
- 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
- Patients who are at the University Hospitals Cleveland Medical Center Mohs Clinic to undergo a linear closure on the face.
- Fluent English speakers
Who cannot join
- Non-fluent English speakers
About this study
Official title: 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.
Read the 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.
- Conditions
- Mohs Surgery
- Being tested
- Pre-Operative Videos, verbal instructions, written instructions
- Keywords
- anxiety, patient satisfaction, video education, skin cancer, linear closure on the face
- Medical subject headings
- Anxiety Disorders, Patient Satisfaction, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Operative VideosBehavioural
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.
verbal instructionsBehavioural
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
written instructionsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Pre-Operative Videos + verbal/written instructions | Experimental | 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. Receives: Behavioral: Pre-Operative Videos; Behavioral: verbal instructions; Behavioral: written instructions |
| verbal/written instructions | Active comparator | 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 Receives: Behavioral: verbal instructions; Behavioral: written instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 8 weeks after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Jun 2018
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mohs SurgeryStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy S. Bordeaux, MD, MPH, Principal investigator, University Hospitals, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485937
- Sponsor's protocol ID
- CASE1618
- Status last verified
- Oct 2019
- First submitted
- 27 Mar 2018
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre-Operative Videos on Mohs Surgery Patient Anxiety and Satisfaction
- ClinicalTrials.gov ID
- NCT03485937
- Acronym / sponsor ID
- CASE1618
- Conditions
- Mohs Surgery
- Keywords
- anxiety, patient satisfaction, video education, skin cancer, linear closure on the face
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 3 Apr 2018 (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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Operative Videos + verbal/written instructions | Experimental | Behavioral: Pre-Operative Videos, Behavioral: verbal instructions, Behavioral: written instructionsThis 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. |
| verbal/written instructions | Active comparator | Behavioral: verbal instructions, Behavioral: written instructionsThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are at the University Hospitals Cleveland Medical Center Mohs Clinic to undergo a linear closure on the face.
- Fluent English speakers
Key exclusion criteria (1 listed)
- Non-fluent English speakers
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 |
|---|---|---|
| Pre-Operative VideosVideos 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. | Behavioural | Pre-Operative Videos + verbal/written instructions |
| verbal instructionsAs part of the standard of care for patients receiving Mohs surgery, patients are told about the day of their surgery and what to expect | Behavioural | Pre-Operative Videos + verbal/written instructions, verbal/written instructions |
| written instructionsAs 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 | Behavioural | Pre-Operative Videos + verbal/written instructions, verbal/written instructions |
Primary outcome
Difference in mean Likert scale rating of subject satisfaction score
Time frame: Up to 8 weeks after visit
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.
Difference in mean Likert scale rating of subject anxiety score
Time frame: Up to 8 weeks after visit
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
Related trials for Mohs Surgery
Not yet recruitingPhase 1
Amnion Membrane Powder Mohs Study
Wound Heal
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Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
Surgical Site Infection, Skin Cancer
Not yet recruitingPhase 2
The Effects of Timolol On Healing and Cosmesis of Mohs Scalp Wounds: An Open Label Trial
Surgical Wounds, Mohs Surgery
Not yet recruitingPhase 4
Skin Subs vs Secondary Intention
Skin Substitutes, Secondary Intention Healing
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Intraoperative CO₂ (Carbon Dioxide)
Wound Edges
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.
Jeremy S. Bordeaux, MD, MPH principal investigator
University Hospitals, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Operative Videos, verbal instructions and written instructions in people with Mohs Surgery, run by Case Comprehensive Cancer Center.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Difference in mean Likert scale rating of subject satisfaction score (time frame: Up to 8 weeks after visit). The study lists 2 primary outcomes in all. 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 22 Oct 2019.