Effect of the Subconscious on Mohs Micrographic Surgery

July 14, 2014 updated by: Northwestern University
The goal of this study is to determine if relaxation therapy improves patient satisfaction with Mohs micrographic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Murad Alam, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient anxiety
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Scar appearance
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 7, 2006

First Submitted That Met QC Criteria

September 7, 2006

First Posted (Estimate)

September 8, 2006

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1253-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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