Clinical trial NCT04420208: Ameliorating the Obstacle of Pap Smear
Official title: Ameliorating the Obstacle of Pap Smear: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Cervical cancer screening
Pap smear
Procedural pain
Peak-end rule
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 268
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recalled pain just after the Pap smear test using a 1-5 numeric scale
timeFrame: Five minutes after the Pap test
measure: Recalled pain just after the Pap smear test using a a 0-10 visual analog scale
timeFrame: Five minutes after the Pap test
Secondary outcomes:
measure: Real-time pain during the Pap test using a 1-5 numeric scale
timeFrame: Every five seconds throughout the Pap test
measure: Long-term recalled pain after the Pap test using a 1-5 numeric scale
timeFrame: One year after the Pap test
measure: Long-term recalled pain after the Pap test using a 0-10 visual analog scale
timeFrame: One year after the Pap test
measure: Willingness to receive further Pap tests
timeFrame: One year after the Pap test
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hosputal
Study officials:
affiliation: Attending physician
name: Chien-Hsieh Chiang, MD, MPH
role: STUDY_CHAIR
References: