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CompletedNCT00520117Updated Sep 30, 2019

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

An observational study in Papanicolaou Smear, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Mahidol University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
151
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Papanicolaou Smear
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In context

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients having pap-smear at Ratchawithi Hospital

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
151 participants (actual)

Groups and cohorts

  • negative pap-smear
  • positive pap-smear
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What researchers measure

Primary outcomes

  1. psychological burden of women with abnormal pap-smear

    Time frame: 3 months

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Study locations

1 site
  • Clinical Infectious Diseases Research Unit
    Bangkok, 10400, Thailand
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00520117
Lead sponsor
Mahidol University
Responsible party
Punnee Pitisuttithum (Professor, Mahidol University) — Principal investigator
First posted
Aug 23, 2007
Start date
Jun 2007
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Sep 30, 2019

Study contacts

Punnee Pitisuttithum, Professor
principal investigator · Department of Clinical ITropical Medicine, Faculty of Tropical Medicine, Mahidol University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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