Effect of the Subconscious on Mohs Micrographic Surgery

Squamous Cell Carcinoma Clinical Trial

Official title:

Effect of the Subconscious on Mohs Micrographic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374062
• Other study ID #: 1253-017
• Status: Completed
• Phase: N/A
• First received: September 7, 2006
• Last updated: July 14, 2014
• Start date: December 2007
• Est. completion date: August 2009

Study information

• Verified date: July 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Behavioral:
• relaxation therapy 1
relaxation therapy 1
• relaxation therapy 2
relaxation therapy 2
• relaxation therapy 3
relaxation therapy 3

Locations

Country	Name	City	State
United States	Murad Alam, MD	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient anxiety		1 day	No
Secondary	Scar appearance		12 weeks	No