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Ameliorating the Obstacle of Pap Smear

NCT ID: NCT04420208

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-28

Study Completion Date

2021-10-11

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.

Conditions

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Pain

Keywords

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Cervical cancer screening Pap smear Procedural pain Peak-end rule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Modified Pap test

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

Group Type EXPERIMENTAL

Modified Pap test

Intervention Type PROCEDURE

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

Traditional Pap test

Traditional Pap-smear procedure as control.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Modified Pap test

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chien-Hsieh Chiang, MD, MPH

Role: STUDY_CHAIR

Attending physician

Locations

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National Taiwan University Hosputal

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 37043729 (View on PubMed)

Other Identifiers

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202004014RINB

Identifier Type: -

Identifier Source: org_study_id