Effect of the Subconscious on Mohs Micrographic Surgery | NCT00374062

Studies
Effect of the Subconscious on Mohs Micrographic Surgery

NCT00374062

Sponsor

Northwestern University

Status

Completed

Last Update Posted

Jul 15, 2014Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Basal Cell Carcinoma
Squamous Cell Carcinoma

Interventions

relaxation therapy 1
relaxation therapy 2
relaxation therapy 3

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

Jul 2014

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

Dec 2007

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Sep 7, 2006

First Submission Date that Met QC Criteria

Sep 7, 2006

First Posted Date

Sep 8, 2006Estimated

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

Jul 14, 2014

Last Update Posted Date

Jul 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 goal of this study is to determine if relaxation therapy improves patient satisfaction with Mohs micrographic surgery.

Detailed Description

Patients are instructed in relaxation techniques. The goal of this study is to determine how relaxation techniques affect the patient's Mohs micrographic surgery experience.

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Experimental	relaxation tape 1	Behavioral: relaxation therapy 1
II	Experimental	relaxation tape 2	Behavioral: relaxation therapy 2
III	Placebo Comparator	relaxation tape 3	Behavioral: relaxation therapy 3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
relaxation therapy 1	Behavioral	relaxation therapy 1	I
relaxation therapy 2

Measure	Description	Time Frame
Patient anxiety		1 day

Measure	Description	Time Frame
Scar appearance		12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 25 and older
Subjects are undergoing micrographic Mohs surgery for facial basal and squamous cell carcinoma.
The subjects are in good health.
The subjects have willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

Subjects who have wound healing problems.
Subjects who have had prior Mohs surgery.
Subjects who are smokers.
Subjects who are currently using anticoagulation therapy
Subjects who have a history of bleeding disorders.
Subjects who are unable to understand the protocol or to give informed consent
Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders, cognitive disorders, depression with psychotic features, dissociative disorders.
Subjects who are taking medications that may affect healing such as prednisone, or any immunosuppressants.
Subjects who are immunocompromised.
Subjects who have Diabetes Mellitus or any other condition determined by the PI to affect healing.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Murad Alam, MD	Northwestern University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Murad Alam, MD		Chicago	Illinois	60611	United States

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided