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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

September 7, 2006
July 14, 2014
December 2007
August 2009   (final data collection date for primary outcome measure)
Patient anxiety [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Patient anxiety
  • Scar appearance
Complete list of historical versions of study NCT00374062 on ClinicalTrials.gov Archive Site
Scar appearance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effect of the Subconscious on Mohs Micrographic Surgery
Effect of the Subconscious on Mohs Micrographic Surgery

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma
  • Behavioral: relaxation therapy 1
    relaxation therapy 1
  • Behavioral: relaxation therapy 2
    relaxation therapy 2
  • Behavioral: relaxation therapy 3
    relaxation therapy 3
  • Experimental: I
    relaxation tape 1
    Intervention: Behavioral: relaxation therapy 1
  • Experimental: II
    relaxation tape 2
    Intervention: Behavioral: relaxation therapy 2
  • Placebo Comparator: III
    relaxation tape 3
    Intervention: Behavioral: relaxation therapy 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
25 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374062
1253-017
No
Murad Alam, MD, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP