Effect of the Subconscious on Mohs Micrographic Surgery
This study has been completed.
Sponsor:
Northwestern University
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00374062
First received: September 7, 2006
Last updated: May 25, 2011
Last verified: May 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The goal of this study is to determine if relaxation therapy improves patient satisfaction with Mohs micrographic surgery.
| Condition | Intervention |
|---|---|
|
Basal Cell Carcinoma Squamous Cell Carcinoma |
Behavioral: relaxation therapy 1 Behavioral: relaxation therapy 2 Behavioral: relaxation therapy 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of the Subconscious on Mohs Micrographic Surgery |
Resource links provided by NLM:
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- Patient anxiety [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Scar appearance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2007 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Murad Alam, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00374062 History of Changes |
| Other Study ID Numbers: | 1253-017 |
| Study First Received: | September 7, 2006 |
| Last Updated: | May 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Mohs Surgery |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Basal Cell Neoplasms, Squamous Cell |
ClinicalTrials.gov processed this record on June 18, 2013