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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University
ClinicalTrials.gov Identifier:
NCT00520117
First received: August 22, 2007
Last updated: December 27, 2013
Last verified: August 2007
  Purpose

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 Phase
Papanicolaou Smear
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • psychological burden of women with abnormal pap-smear [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 151
Study Start Date: June 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
negative pap-smear
positive pap-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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Punnee Pitisuttithum, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT00520117     History of Changes
Other Study ID Numbers: 2007-024
Study First Received: August 22, 2007
Last Updated: December 27, 2013
Health Authority: Thailand: Ethical Committee

ClinicalTrials.gov processed this record on October 29, 2014