Ameliorating the Obstacle of Pap Smear

National Taiwan University

Status: Completed

Conditions: Pain

Treatments: Procedure: Modified Pap test

Study type: Interventional

Funder types: Other

Identifiers

NCT04420208

202004014RINB

Details and patient eligibility

About

To reduce the procedural pain of Pap smear, this study expects to apply the peak-end rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix. This study aims to conduct a randomized controlled study at a tertiary center, National Taiwan University Hospital (NTUH). The investigators expect to compare the recalled pain intensity of the intervention and control groups.

Full description

Purpose: In order to reduce the procedural pain, this study expects to apply the peak-end rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix. Methods: This study aims to conduct a randomized controlled study at NTUH. Approximately 200 subjects are expected to be recruited. The investigators will utilize the peak-end rule by adding a non-painful step right after the most uncomfortable phase in the intervention group. All study subjects are requested to score on a numeric pain scale during the Pap test. All operators experienced in techniques for performing a Pap test should attend workshops for a standard operating procedure. A well-trained research assistant is also responsible for ensuring standardization of procedures to eliminate interoperator variability. The primary outcome was the recalled pain intensity at five minutes after the Pap smear test.

Enrollment: 268 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Biological female
• Aged 30-70
• Provision of written informed consent

Exclusion criteria

• Pregnancy
• Active vaginal or uterus infection
• Incapable of understanding the numeric pain scales
• Prior cervical cancer diagnosis
• Prior hysterectomy, pelvic or vaginal surgery
• Ongoing menstruation
• Use of painkillers within 24 hours

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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268 participants in 2 patient groups

Modified Pap test

Experimental group

Description:

Adding a non-painful event after the most uncomfortable phase of Pap smear.

Treatment:

Procedure: Modified Pap test

Traditional Pap test

No Intervention group

Description:

Traditional Pap-smear procedure as control.