Ameliorating the Obstacle of Pap Smear

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ameliorating the Obstacle of Pap Smear: a Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Procedure: Modified Pap test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects are divided into two groups, one with traditional Pap smear and one with Pap smear adding a non-painful procedure at the end. The investigators will compare the real-time pain score and recalled pain to check whether the theory works.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer screening, Pap smear, Procedural pain, Peak-end rule