Can Alternative Treatment Have an Impact on Cervical Dysplasia?

Cervical Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00842738
• Other study ID #: UP05010
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: February 10, 2009
• Last updated: January 13, 2010
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years to 29 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

Behavioral:
• Mindfulness meditation
Mindfulness meditation

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

Locations

Country	Name	City	State
Denmark	Department and Research Unit of General Practice, Institute of Public Health	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of cervical dysplasia		6 months after screening	No
Secondary	Psychosocial consequences measured with the COS-CC questionnaire		1 week, 3 and 9 months after screening	No