Ameliorating the Obstacle of Pap Smear

Pain Clinical Trial

Official title:

Ameliorating the Obstacle of Pap Smear: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420208
• Other study ID #: 202004014RINB
• Status: Completed
• Phase: N/A
• Start date: May 28, 2020
• Est. completion date: October 11, 2021

Study information

• Verified date: October 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: October 11, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Modified Pap test
Adding a non-painful step after the most uncomfortable phase of Pap smear

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hosputal	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Willingness to receive further Pap tests	0-10 grades (0: unwillingness; 10: highest grade of willingness)	One year after the Pap test