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: July 14, 2014
Last verified: July 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 14, 2014
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 July 22, 2014