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Effect of the Subconscious on Mohs Micrographic Surgery

Primary Purpose

Basal Cell Carcinoma, Squamous Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
relaxation therapy 1
relaxation therapy 2
relaxation therapy 3
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Mohs Surgery

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Murad Alam, MD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

I

II

III

Arm Description

relaxation tape 1

relaxation tape 2

relaxation tape 3

Outcomes

Primary Outcome Measures

Patient anxiety

Secondary Outcome Measures

Scar appearance

Full Information

First Posted
September 7, 2006
Last Updated
July 14, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00374062
Brief Title
Effect of the Subconscious on Mohs Micrographic Surgery
Official Title
Effect of the Subconscious on Mohs Micrographic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Squamous Cell Carcinoma
Keywords
Mohs Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
relaxation tape 1
Arm Title
II
Arm Type
Experimental
Arm Description
relaxation tape 2
Arm Title
III
Arm Type
Placebo Comparator
Arm Description
relaxation tape 3
Intervention Type
Behavioral
Intervention Name(s)
relaxation therapy 1
Intervention Description
relaxation therapy 1
Intervention Type
Behavioral
Intervention Name(s)
relaxation therapy 2
Intervention Description
relaxation therapy 2
Intervention Type
Behavioral
Intervention Name(s)
relaxation therapy 3
Intervention Description
relaxation therapy 3
Primary Outcome Measure Information:
Title
Patient anxiety
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Scar appearance
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Murad Alam, MD
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Effect of the Subconscious on Mohs Micrographic Surgery

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