Can Alternative Treatment Have an Impact on Cervical Dysplasia?

Overview

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?

Full Title of Study: “Can Mindfulness Meditation Limit the Progression and/or Increase the Remission of Cervical Dysplasia?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2010

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.

Interventions

  • Behavioral: Mindfulness meditation
    • Mindfulness meditation
  • Other: No meditation
    • Health care services as usual
  • Other: Controls
    • No intervention

Arms, Groups and Cohorts

  • Active Comparator: Mindfulness meditation
    • Women with mild dysplasia offered mindfulness meditation
  • Other: No meditation
    • Women with mild dysplasia offered health care services as usual
  • Other: Controls
    • Women with normal cervical cells

Clinical Trial Outcome Measures

Primary Measures

  • The degree of cervical dysplasia
    • Time Frame: 6 months after screening

Secondary Measures

  • Psychosocial consequences measured with the COS-CC questionnaire
    • Time Frame: 1 week, 3 and 9 months after screening

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 23 Years

Maximum Age: 29 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Copenhagen
  • Collaborator
    • Danish Cancer Society
  • Provider of Information About this Clinical Study
    • John Brodersen, MD, GP, PhD, Associate Professor, Department and Research Unit of G.P., Institute of Public Health, Uni of Copenhagen

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