Can Alternative Treatment Have an Impact on Cervical Dysplasia?

Phase 4

• Conditions: Cervical Dysplasia
• Interventions: Behavioral: Mindfulness meditation; Other: No meditation; Other: Controls

• Registration Number: NCT00842738
• Lead Sponsor: 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?

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 Timeline

• Status Verified: 2009-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Study Start: 2009-03
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14
• Primary Completion: 2010-06
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness meditation	Mindfulness meditation	Women with mild dysplasia offered mindfulness meditation
No meditation	No meditation	Women with mild dysplasia offered health care services as usual
Controls	Controls	Women with normal cervical cells

Primary Outcome Measures

Name	Time	Method
The degree of cervical dysplasia	6 months after screening

Secondary Outcome Measures

Name	Time	Method
Psychosocial consequences measured with the COS-CC questionnaire	1 week, 3 and 9 months after screening

Trial Locations

Locations (1)

Department and Research Unit of General Practice, Institute of Public Health; 🇩🇰 Copenhagen, Denmark