Effect of the Subconscious on Mohs Micrographic Surgery - Full Text View

Sponsored by:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00374062

Purpose

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

Condition	Intervention
Basal Cell Carcinoma Squamous Cell Carcinoma	Behavioral: relaxation therapy 1 Behavioral: relaxation therapy 2 Behavioral: relaxation therapy 3

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of the Subconscious on Mohs Micrographic Surgery

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Patient anxiety [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scar appearance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	December 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental relaxation tape 1	Behavioral: relaxation therapy 1 relaxation therapy 1
II: Experimental relaxation tape 2	Behavioral: relaxation therapy 2 relaxation therapy 2
III: Placebo Comparator relaxation tape 3	Behavioral: relaxation therapy 3 relaxation therapy 3

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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374062

Contacts

Contact: Murad Alam, MD

312-695-6785

m-alam@northwestern.edu

Locations

United States, Illinois
Northwestern Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60611
Contact: Murad Alam 312-707-2114 m-alam@northwestern.edu
Murad Alam, MD	Recruiting
Chicago, Illinois, United States, 60611
Contact: Murad Alam, MD 312-695-6785 m-alam@northwestern.edu

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Murad Alam, MD

Northwestern University

More Information

Responsible Party:	Northwestern University ( Murad Alam, MD )
Study ID Numbers:	1253-017
Study First Received:	September 7, 2006
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00374062
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

Mohs Surgery

Study placed in the following topic categories:

Epidermoid carcinoma
Squamous cell carcinoma
Carcinoma, squamous cell
Carcinoma, Basal Cell

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on January 16, 2009