Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions

Papanicolaou Smear Clinical Trial

Official title:

Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520117
• Other study ID #: 2007-024
• Status: Completed
• Start date: June 2007
• Est. completion date: June 2008

Study information

• Verified date: September 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary purpose of this study is to assess the psychosocial burden in women who have experienced an abnormal pap results after screening interventions.

Description:

This study will be a Thailand, clinic-based, cross-sectional, questionnaire study. Approximately 151 female participants will be enrolled. Study staff will interview the subject to collect basis demographic data and self reported medical history. And the subjects will be given the questionnaire packet for self-administration. After subjects complete the packet, study staff will review the questionnaires for completeness prior to the study subject leaving the clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months.

Exclusion Criteria:

• has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives

• has other concurrent/active STD's

• has a history of known prior vaccination with an HPV vaccine

• has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse.

Related Conditions & MeSH terms

• Papanicolaou Smear

Locations

Country	Name	City	State
Thailand	Clinical Infectious Diseases Research Unit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychological burden of women with abnormal pap-smear		3 months