Basal Cell CarcinomaNCT00374062
Effect of the Subconscious on Mohs Micrographic Surgery
A study testing relaxation therapy 1, relaxation therapy 2 and relaxation therapy 3 in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this study is to determine if relaxation therapy improves patient satisfaction with Mohs micrographic surgery. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- relaxation therapy 1, relaxation therapy 2 and relaxation therapy 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
The goal of this study is to determine if relaxation therapy improves patient satisfaction with Mohs micrographic surgery.
Read the 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.
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- Being tested
- relaxation therapy 1, relaxation therapy 2, relaxation therapy 3
- Keywords
- Mohs Surgery
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation therapy 1Behavioural
relaxation therapy 1
relaxation therapy 2Behavioural
relaxation therapy 2
relaxation therapy 3Behavioural
relaxation therapy 3
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | relaxation tape 1 Receives: Behavioral: relaxation therapy 1 |
| II | Experimental | relaxation tape 2 Receives: Behavioral: relaxation therapy 2 |
| III | Placebo comparator | relaxation tape 3 Receives: Behavioral: relaxation therapy 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient anxiety
Measured: 1 day
Secondary outcomes (1)
Scar appearance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startDec 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374062
- Sponsor's protocol ID
- 1253-017
- Status last verified
- Jul 2014
- First submitted
- 7 Sep 2006
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Subconscious on Mohs Micrographic Surgery
- ClinicalTrials.gov ID
- NCT00374062
- Acronym / sponsor ID
- 1253-017
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- Keywords
- Mohs Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: relaxation therapy 1relaxation tape 1 |
| II | Experimental | Behavioral: relaxation therapy 2relaxation tape 2 |
| III | Placebo comparator | Behavioral: relaxation therapy 3relaxation tape 3 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relaxation therapy 1relaxation therapy 1 | Behavioural | I |
| relaxation therapy 2relaxation therapy 2 | Behavioural | II |
| relaxation therapy 3relaxation therapy 3 | Behavioural | III |
Primary outcome
Patient anxiety
Time frame: 1 day
1 secondary outcome
Scar appearance
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relaxation therapy 1, relaxation therapy 2 and relaxation therapy 3 in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient anxiety (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.