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Can Alternative Treatment Have an Impact on Cervical Dysplasia?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00842738
Recruitment Status : Unknown
Verified February 2009 by University of Copenhagen.
Recruitment status was:  Enrolling by invitation
First Posted : February 12, 2009
Last Update Posted : January 14, 2010
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by:
University of Copenhagen

Tracking Information
First Submitted Date  ICMJE February 10, 2009
First Posted Date  ICMJE February 12, 2009
Last Update Posted Date January 14, 2010
Study Start Date  ICMJE March 2009
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2009)
The degree of cervical dysplasia [ Time Frame: 6 months after screening ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2009)
Psychosocial consequences measured with the COS-CC questionnaire [ Time Frame: 1 week, 3 and 9 months after screening ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Alternative Treatment Have an Impact on Cervical Dysplasia?
Official Title  ICMJE Can Mindfulness Meditation Limit the Progression and/or Increase the Remission of Cervical Dysplasia?
Brief Summary

In this study two questions will be answered:

  • can mindfulness meditation help cell-changed on the cervix to disappear?
  • can mindfulness meditation lower the psychological distress when women have abnormal cervical cancer screening results?
Detailed Description 200 women, who have participated in cervical cancer screening and have mild dysplasia, will be randomized into two groups; an intervention group and a control group. The intervention group will be asked to do mindfulness meditation twice a week listening to instructions from a CD. 200 additional women having normal cervical screening results will also be included in the project.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Dysplasia
Intervention  ICMJE
  • Behavioral: Mindfulness meditation
    Mindfulness meditation
  • Other: No meditation
    Health care services as usual
  • Other: Controls
    No intervention
Study Arms  ICMJE
  • Active Comparator: Mindfulness meditation
    Women with mild dysplasia offered mindfulness meditation
    Intervention: Behavioral: Mindfulness meditation
  • No meditation
    Women with mild dysplasia offered health care services as usual
    Intervention: Other: No meditation
  • Controls
    Women with normal cervical cells
    Intervention: Other: Controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 11, 2009)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women aged 23-29 years
  • Participated in cervical cancer screening
  • Having mild dysplasia and normal screening results

Exclusion Criteria:

  • Women who have previously had dysplasia
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 23 Years to 29 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00842738
Other Study ID Numbers  ICMJE UP05010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Brodersen, MD, GP, PhD, Associate Professor, Department and Research Unit of G.P., Institute of Public Health, Uni of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Danish Cancer Society
Investigators  ICMJE Not Provided
PRS Account University of Copenhagen
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP