Actively Recruiting

Phase Not Applicable
Age: 25Years +
FEMALE
ID06968871

Effects of the Ameliorated Pap Test on Cervical Cancer Screening Participation: a Multicenter Randomized Controlled Trial

Led by National Taiwan University Hospital · Updated on 2026-03-03

248

Participants Needed

5

Research Sites

104 weeks

Total Duration

On this page

Sponsors

N

National Taiwan University Hospital

Lead Sponsor

N

National Taiwan University Hospital Hsin-Chu Branch

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new approach to Pap smear screening to improve cervical cancer screening participation among women aged 25 and above. This multicenter randomized controlled trial applies the peak-end concept by adding a non-painful step at the end of the Pap test. The study is the first to examine whether this modified Pap test can increase participation rates in cervical cancer screening and reduce recalled pain related to the procedure. Participants are randomly assigned to receive either the traditional Pap test or a modified version where, after sample collection, the speculum remains fixed in place for 15 seconds before removal. This additional step is designed to be non-painful and is performed behind a privacy curtain. All operators follow standardized procedures, and the study includes blinding of participants and cytopathologists to group assignments. The trial plans to recruit at least 248 women across multiple centers in the NTUH Healthcare System, with half receiving the modified test. During the study, participants provide written informed consent and undergo interviews to collect health, lifestyle, and psychological information. Measurements include anxiety scores, pain ratings at various time points, and medical history. Researchers will analyze cervical cancer screening participation at 1 and 3 years, along with real-time and recalled pain scores. The study includes careful monitoring and statistical analyses to assess the effect of the intervention on screening uptake and pain perception over time.

CONDITIONS

Brief Title

Ameliorated Pap Tests and Cervical Cancer Screening Participation

Who Can Participate

Age: 25Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 25 or above
Not Eligible

You will not qualify if you...

  • Ongoing menstruation
  • Pregnancy
  • Incapability of understanding the numeric pain scales
  • Any active cancer at study entry (diagnosed or treated within the previous 6 months, recurrent, regionally advanced or metastatic cancer)
  • Previous hysterectomy, pelvic surgery, or radiotherapy
  • Active vaginal or uterus infection
  • Analgesic use within 24 hours

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Screening Procedure

Duration - Single day

Participants receive either the traditional Pap test or the modified Pap test. The Pap test involves specimen collection for cervical cytology with a privacy curtain separating participants from operators. Those in the modified Pap test group experience an additional 15-second step with the speculum in place, which does not affect specimen quality or cause pain.

1 visit (in-person) for the Pap test procedure

Post-Test Assessment

Duration - Up to 3 months after the Pap test

Participants complete pain evaluations immediately and up to 3 months after the Pap test. Information on tobacco use, alcohol consumption, socioeconomic status, medical history, anxiety, and psychological stress is collected through interviews and measurements.

1 visit for immediate pain assessment and follow-up assessments up to 3 months

Long-term Monitoring

Duration - 3 years

Participants are monitored for cervical cancer screening participation over 3 years to assess the impact of the Pap test intervention on screening uptake.

Follow-up contacts or assessments to record screening participation during 3 years

Trial Site Locations

Total: 5 locations

1

National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan

Actively Recruiting

2

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

Actively Recruiting

3

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

4

National Taiwan University Cancer Center

Taipei, Taiwan

Actively Recruiting

5

National Taiwan University Hospital Beihu Branch

Taipei, Taiwan

Actively Recruiting

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Research Team

C

Chien-Hsieh Chiang, MD, MPH, PhD

Y

Yu-Chung Wu, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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Published Research Related To This Trial

A randomized, double-blind water taste test to evaluate the equivalence of taste between tap water and filtered water in the Taipei metropolis.

Jing-Rong Jhuang, Wen-Chung Lee, Chang-Chuan Chan

https://pubmed.ncbi.nlm.nih.gov/32770131