Effect of the Subconscious on Mohs Micrographic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00374062
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : July 15, 2014
Information provided by:
Northwestern University

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

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Squamous Cell Carcinoma Behavioral: relaxation therapy 1 Behavioral: relaxation therapy 2 Behavioral: relaxation therapy 3 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of the Subconscious on Mohs Micrographic Surgery
Study Start Date : December 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: I
relaxation tape 1
Behavioral: relaxation therapy 1
relaxation therapy 1
Experimental: II
relaxation tape 2
Behavioral: relaxation therapy 2
relaxation therapy 2
Placebo Comparator: III
relaxation tape 3
Behavioral: relaxation therapy 3
relaxation therapy 3

Primary Outcome Measures :
  1. Patient anxiety [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Scar appearance [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00374062

United States, Illinois
Murad Alam, MD
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Murad Alam, MD Northwestern University

Responsible Party: Murad Alam, MD, Northwestern University Identifier: NCT00374062     History of Changes
Other Study ID Numbers: 1253-017
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014

Keywords provided by Northwestern University:
Mohs Surgery

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms, Basal Cell