Effect of the Subconscious on Mohs Micrographic Surgery

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00374062
First received: September 7, 2006
Last updated: May 25, 2011
Last verified: May 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of the Subconscious on Mohs Micrographic Surgery

Resource links provided by NLM:


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
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

No publications provided

Responsible Party: Murad Alam, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00374062     History of Changes
Other Study ID Numbers: 1253-017
Study First Received: September 7, 2006
Last Updated: May 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Mohs Surgery

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

ClinicalTrials.gov processed this record on April 17, 2014