Effect of the Subconscious on Mohs Micrographic Surgery

Northwestern University

Status: Completed

Conditions: Squamous Cell Carcinoma; Basal Cell Carcinoma

Treatments: Behavioral: relaxation therapy 1; Behavioral: relaxation therapy 3; Behavioral: relaxation therapy 2

Study type: Interventional

Funder types: Other

Identifiers

NCT00374062

1253-017

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

I

Experimental group

Description:

relaxation tape 1

Treatment:

Behavioral: relaxation therapy 1

II

Experimental group

Description:

relaxation tape 2

Treatment:

Behavioral: relaxation therapy 2

III

Placebo Comparator group

Description:

relaxation tape 3

Treatment:

Behavioral: relaxation therapy 3