Ameliorating the Obstacle of Pap Smear

Ameliorating the Obstacle of Pap Smear: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: Modified Pap test

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 Type: Interventional
• Enrollment (Actual): 268
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hosputal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Pap test; Adding a non-painful event after the most uncomfortable phase of Pap smear.	Procedure: Modified Pap test; Adding a non-painful step after the most uncomfortable phase of Pap smear
No Intervention: Traditional Pap test; Traditional Pap-smear procedure as control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recalled pain just after the Pap smear test using a 1-5 numeric scale	This recalled pain intensity is evaluated with a 1-5 numeric scale (1:no pain; 5: maximal pain).	Five minutes after the Pap test
Recalled pain just after the Pap smear test using a a 0-10 visual analog scale	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.	Five minutes after the Pap test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-time pain during the Pap test using a 1-5 numeric scale	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.	Every five seconds throughout the Pap test
Long-term recalled pain after the Pap test using a 1-5 numeric scale	Evaluated with a 1-5 numeric scale (1: no pain; 5: maximal pain).	One year after the Pap test
Long-term recalled pain after the Pap test using a 0-10 visual analog scale	Evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain).	One year after the Pap test
Willingness to receive further Pap tests	0-10 grades (0: unwillingness; 10: highest grade of willingness)	One year after the Pap test

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Chien-Hsieh Chiang, MD, MPH, Attending physician

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 11, 2021

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Pap smear; Procedural pain; Cervical cancer screening; Peak-end rule
• Other Study ID Numbers: 202004014RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No