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

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ClinicalTrials.gov Identifier: NCT00520117
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University

Brief 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.

Condition or disease
Papanicolaou Smear

Detailed 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.

Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions
Study Start Date : June 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Group/Cohort
negative pap-smear
positive pap-smear



Primary Outcome Measures :
  1. psychological burden of women with abnormal pap-smear [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients having pap-smear at Ratchawithi Hospital
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520117


Locations
Thailand
Clinical Infectious Diseases Research Unit
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Punnee Pitisuttithum, Professor Department of Clinical ITropical Medicine, Faculty of Tropical Medicine, Mahidol University

Responsible Party: Punnee Pitisuttithum, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT00520117     History of Changes
Other Study ID Numbers: 2007-024
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: August 2007