PainNCT04420208
Ameliorating the Obstacle of Pap Smear
A study testing Modified Pap test in people with Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Modified Pap test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 May 2020to 11 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Biological female
- Aged 30-70
- Provision of written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ameliorating the Obstacle of Pap Smear: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Modified Pap test
- Keywords
- Cervical cancer screening, Pap smear, Procedural pain, Peak-end rule
- Medical subject headings
- Pain, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Pap testProcedure or surgery
Adding a non-painful step after the most uncomfortable phase of Pap smear
| Study group | Role | What they receive |
|---|---|---|
| Modified Pap test | Experimental | Adding a non-painful event after the most uncomfortable phase of Pap smear. Receives: Procedure: Modified Pap test |
| Traditional Pap test | No intervention | Traditional Pap-smear procedure as control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Five minutes after the Pap test
Secondary outcomes (4)
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.
Measured: Every five seconds throughout the Pap test
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).
Measured: One year after the Pap test
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).
Measured: One year after the Pap test
Willingness to receive further Pap tests
0-10 grades (0: unwillingness; 10: highest grade of willingness)
Measured: One year after the Pap test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start28 May 2020
- Primary completion31 Oct 2020
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Hsieh Chiang, MD, MPH, Study chair, Attending physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420208
- Sponsor's protocol ID
- 202004014RINB
- Status last verified
- Oct 2021
- First submitted
- 4 Jun 2020
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37043729
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ameliorating the Obstacle of Pap Smear: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04420208
- Acronym / sponsor ID
- 202004014RINB
- Conditions
- Pain
- Keywords
- Cervical cancer screening, Pap smear, Procedural pain, Peak-end rule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Modified Pap test | Experimental | Procedure: Modified Pap testAdding a non-painful event after the most uncomfortable phase of Pap smear. |
| Traditional Pap test | No intervention | –Traditional Pap-smear procedure as control. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biological female
- Aged 30-70
- Provision of written informed consent
Key exclusion criteria (7 listed)
- Pregnancy
- Active vaginal or uterus infection
- Incapable of understanding the numeric pain scales
- Prior cervical cancer diagnosis
- Prior hysterectomy, pelvic or vaginal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Pap testAdding a non-painful step after the most uncomfortable phase of Pap smear | Procedure or surgery | Modified Pap test |
Primary outcome
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).
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.
4 secondary outcomes
Real-time pain during the Pap test using a 1-5 numeric scale
Time frame: Every five seconds throughout the Pap test
Long-term recalled pain after the Pap test using a 1-5 numeric scale
Time frame: One year after the Pap test
Long-term recalled pain after the Pap test using a 0-10 visual analog scale
Time frame: One year after the Pap test
Willingness to receive further Pap tests
Time frame: One year after the Pap test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Derived from this study: PubMed 37043729Yen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Hsieh Chiang, MD, MPH study chair
Attending physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Pap test in people with Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recalled pain just after the Pap smear test using a 1-5 numeric scale (time frame: Five minutes after the Pap test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.