Can Alternative Treatment Have an Impact on Cervical Dysplasia?

January 13, 2010 updated by: University of Copenhagen

Can Mindfulness Meditation Limit the Progression and/or Increase the Remission of Cervical Dysplasia?

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 1014
        • Department and Research Unit of General Practice, Institute of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mindfulness meditation
Women with mild dysplasia offered mindfulness meditation
Behavioral: Mindfulness meditation
Mindfulness meditation
Other: No meditation
Women with mild dysplasia offered health care services as usual
Other: No meditation
Health care services as usual
Other: Controls
Women with normal cervical cells
Other: Controls
No intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Danish Cancer Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 13, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP05010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe