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NCT Number: NCT04420208

Ameliorating the Obstacle of Pap Smear

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.

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Key information

Conditions

Pain Neurologic Manifestations Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hosputal

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Pap test

Procedure

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

Primary outcomes

  1. Recalled pain just after the Pap smear test using a 1-5 numeric scale

    Time frame: Five minutes after the Pap test

    This recalled pain intensity is evaluated with a 1-5 numeric scale (1:no pain; 5: maximal pain).

  2. Recalled pain just after the Pap smear test using a a 0-10 visual analog scale

    Time frame: 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 outcomes

  1. Real-time pain during the Pap test using a 1-5 numeric scale

    Time frame: 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.

  2. Long-term recalled pain after the Pap test using a 1-5 numeric scale

    Time frame: One year after the Pap test

    Evaluated with a 1-5 numeric scale (1: no pain; 5: maximal pain).

  3. Long-term recalled pain after the Pap test using a 0-10 visual analog scale

    Time frame: One year after the Pap test

    Evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain).

  4. Willingness to receive further Pap tests

    Time frame: One year after the Pap test

    0-10 grades (0: unwillingness; 10: highest grade of willingness)

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Ameliorating the Obstacle of Pap Smear: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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