Ameliorating the Obstacle of Pap Smear

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: Modified Pap test

• Registration Number: NCT04420208
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-05-28
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Primary Completion: 2020-10-31
• Status Verified: 2021-10
• Study Completion: 2021-10-11
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 268

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Pap test	Modified Pap test	Adding a non-painful event after the most uncomfortable phase of Pap smear.

Primary Outcome Measures

Name	Time	Method
Recalled pain just after the Pap smear test using a 1-5 numeric scale	Five minutes after the Pap test	This recalled pain intensity is evaluated with a 1-5 numeric scale (1:no pain; 5: maximal pain).
Recalled pain just after the Pap smear test using a a 0-10 visual analog scale	Five minutes after the Pap test	This recalled pain intensity is evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain), where pain was categorized as mild, moderate, and severe.

Secondary Outcome Measures

Name	Time	Method
Long-term recalled pain after the Pap test using a 0-10 visual analog scale	One year after the Pap test	Evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain).
Long-term recalled pain after the Pap test using a 1-5 numeric scale	One year after the Pap test	Evaluated with a 1-5 numeric scale (1: no pain; 5: maximal pain).
Real-time pain during the Pap test using a 1-5 numeric scale	Every five seconds throughout the Pap test	The participants are asked to evaluate and record their pain every five seconds throughout the test. The real-time pain is recorded with a 1 to 5 numeric scale (1:no pain; 5: maximal) at the beginning, the first quarter, the second quarter, the third quarter, and the end of the regular course in all participants; as well as right after the additional 15-second step in the group receiving modified Pap tests. The average pain, the maximal pain, as well as real-time pain at the beginning, the first quarter, the second quarter, the third quarter, and the end of the regular course are compared between the two groups. For each group, we also compare the average pain of the first half and the second half of the total course. For participants receiving the modified Pap test, we further compare the average pain, the maximal pain, and the last recorded real-time pain of the 15-second step with that of the regular course.
Willingness to receive further Pap tests	One year after the Pap test	0-10 grades (0: unwillingness; 10: highest grade of willingness)

Trial Locations

Locations (1)

National Taiwan University Hosputal; 🇨🇳 Taipei, Taiwan