Ameliorating the Obstacle of Pap Smear

NCT04420208 | Completed DMC

• 1 other identifier: 202004014RINB
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Cervical cancer screening; Pap smear; Procedural pain; Peak-end rule

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  Every five seconds throughout the Pap test

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

  One year after the Pap test

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

  One year after the Pap test

• Willingness to receive further Pap tests

  One year after the Pap test

Study Arms (2)

Modified Pap test

EXPERIMENTAL

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

Procedure: Modified Pap test

Traditional Pap test

NO INTERVENTION

Traditional Pap-smear procedure as control.

Interventions

Modified Pap test PROCEDURE

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

Modified Pap test

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hosputal

Taipei, 100, Taiwan

Location

Related Publications (1)

• Yen HK, Cheng SY, Chiu KN, Huang CC, Yu JY, Chiang CH; NTUH Pap Study Group. Adding a nonpainful end to reduce pain recollection of Pap smear screening: a randomized controlled trial. Pain. 2023 Aug 1;164(8):1709-1717. doi: 10.1097/j.pain.0000000000002897. Epub 2023 Apr 12.

  PMID: 37043729 DERIVED

MeSH Terms

Conditions

Pain; Pain, Procedural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chien-Hsieh Chiang, MD, MPH

  Attending physician

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During the Pap test, there is a privacy curtain separating participants from the operators. Participants receiving the modified Pap test do not realize what is going on during the 15-second step because they are behind the privacy curtain. The operators performing the procedure are not informed whether to intervene or not by the assistants until a specimen is prepared for cervical cytology. The delayed disclosure of the group allocation until this step ensures the operators standardizing the insertion and opening phases of the Pap test.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: May 28, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 11, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)