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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. 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
Danish Cancer Society
Information provided by:
University of Copenhagen

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?

Condition or disease Intervention/treatment Phase
Cervical Dysplasia Behavioral: Mindfulness meditation Other: No meditation Other: Controls Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can Mindfulness Meditation Limit the Progression and/or Increase the Remission of Cervical Dysplasia?
Study Start Date : March 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Mindfulness meditation
Women with mild dysplasia offered mindfulness meditation
Behavioral: Mindfulness meditation
Mindfulness meditation

No meditation
Women with mild dysplasia offered health care services as usual
Other: No meditation
Health care services as usual

Women with normal cervical cells
Other: Controls
No intervention

Primary Outcome Measures :
  1. The degree of cervical dysplasia [ Time Frame: 6 months after screening ]

Secondary Outcome Measures :
  1. Psychosocial consequences measured with the COS-CC questionnaire [ Time Frame: 1 week, 3 and 9 months after screening ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   23 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00842738

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Department and Research Unit of General Practice, Institute of Public Health
Copenhagen, Denmark, 1014
Sponsors and Collaborators
University of Copenhagen
Danish Cancer Society
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Responsible Party: John Brodersen, MD, GP, PhD, Associate Professor, Department and Research Unit of G.P., Institute of Public Health, Uni of Copenhagen Identifier: NCT00842738    
Other Study ID Numbers: UP05010
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: February 2009
Keywords provided by University of Copenhagen:
Cervical cancer
Cervical dysplasia
Adverse psychosocial effects
Alternative treatment
Additional relevant MeSH terms:
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Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Pathologic Processes
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type