ColposcopyNCT03100565
Lidocaine Spray vs Coughing for Pain Relief During Colposcopy
A study testing local lidocaine spray and forced coughing in people with Colposcopy, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Cervical cancer is the third most common genital cancer worldwide. The diagnosis of cervical cancer is performed with the cervical biopsy which is guided by the colposcopy. The colposcopy guided cervical biopsy creates pain and several methods have been reported to overcome the pain related with this procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Colposcopy
- What is being tested?
- local lidocaine spray and forced coughing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2016to 10 Mar 2018
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age >18,
- Presence of cervix,
- Patients who need a diagnostic work up for abnormal cervical smear results.
Who cannot join
- Pregnancy,
- Presence of already known invasive cancer,
- Allergy to anesthetic agents.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology
Van, 65000
About this study
Official title: Comparison of Lidocaine Spray With Forced Coughing in Pain Relief During Colposcopy Guided Cervical Biopsy Procedure: A Randomized Controlled Trial
Cervical cancer is the third most common genital cancer worldwide. The diagnosis of cervical cancer is performed with the cervical biopsy which is guided by the colposcopy. The colposcopy guided cervical biopsy creates pain and several methods have been reported to overcome the pain related with this procedure. Local anesthetic agent injection into the cervix has been studied and found to be effective and also, forced coughing was compared with local anesthetic injection and it is found to be more effective. In fact local injections can create the pain by itself.However no study compared the effect of forced coughing to local anesthetic spray. The study aims to evaluate the comparison of forced coughing with local anesthetic spray with respect to perceived pain during colposcopy guided biopsy.
- Conditions
- Colposcopy
- Being tested
- local lidocaine spray, forced coughing
- Keywords
- colposcopy, pain, coughing, anesthetic spray
- Medical subject headings
- Pain, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local lidocaine sprayDrug
The lidocaine spray will be introduced to the cervix just before the biopsy procedure
forced coughingOther
The patients will be asked to forced coughing during the biopsy procedure
| Study group | Role | What they receive |
|---|---|---|
| colposcopic biopsy under local anesthetic sp | Placebo comparator | Not described Receives: Drug: local lidocaine spray |
| Patients underwent colposcopic biopsy under forced coughing | Placebo comparator | Not described Receives: Other: forced coughing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during procedure evaluated by the 0-10 cm scale of Visual analog scale (VAS) scoring system
The perceived pain will be measured during the biopsy procedure. It will be evaluated by the 0-10 cm scale of VAS scoring system. The patient will be asked to rate her pain as 0 corresponds ''no pain'' and 10 to the '' worst pain''
Measured: 0-1 min
Secondary outcomes (1)
Pain at the 30th minutes after the procedure evaluated by the 0-10 cm scale of VAS scoring system
The perceived pain will be measured after the biopsy procedure (at the 30th min). It will be evaluated by the 0-10 cm scale of VAS scoring system. The patient will be asked to rate her pain as 0 corresponds ''no pain'' and 10 to the '' worst pain''
Measured: 30. Min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startSep 2016
- Primary completion8 Mar 2018
- Study completion10 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColposcopyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, erbil karaman, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100565
- Sponsor's protocol ID
- YuzuncuYıl
- Status last verified
- Mar 2018
- First submitted
- 17 Mar 2017
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lidocaine Spray With Forced Coughing in Pain Relief During Colposcopy Guided Cervical Biopsy Procedure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03100565
- Acronym / sponsor ID
- YuzuncuYıl
- Conditions
- Colposcopy
- Keywords
- colposcopy, pain, coughing, anesthetic spray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 10 Mar 2018 (actual)
- First posted
- 4 Apr 2017 (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.
Cervical cancer is the third most common genital cancer worldwide. The diagnosis of cervical cancer is performed with the cervical biopsy which is guided by the colposcopy. The colposcopy guided cervical biopsy creates pain and several methods have been reported to overcome the pain related with this procedure. Local anesthetic agent injection into the cervix has been studied and found to be effective and also, forced coughing was compared with local anesthetic injection and it is found to be more effective. In fact local injections can create the pain by itself.However no study compared the effect of forced coughing to local anesthetic spray. The study aims to evaluate the comparison of forced coughing with local anesthetic spray with respect to perceived pain during colposcopy guided biopsy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colposcopic biopsy under local anesthetic sp | Placebo comparator | Drug: local lidocaine spray |
| Patients underwent colposcopic biopsy under forced coughing | Placebo comparator | Other: forced coughing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with age >18,
- Presence of cervix,
- Patients who need a diagnostic work up for abnormal cervical smear results.
Key exclusion criteria (3 listed)
- Pregnancy,
- Presence of already known invasive cancer,
- Allergy to anesthetic agents.
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 |
|---|---|---|
| local lidocaine sprayThe lidocaine spray will be introduced to the cervix just before the biopsy procedure | Drug | colposcopic biopsy under local anesthetic sp |
| forced coughingThe patients will be asked to forced coughing during the biopsy procedure | Other | Patients underwent colposcopic biopsy under forced coughing |
Primary outcome
Pain during procedure evaluated by the 0-10 cm scale of Visual analog scale (VAS) scoring system
Time frame: 0-1 min
The perceived pain will be measured during the biopsy procedure. It will be evaluated by the 0-10 cm scale of VAS scoring system. The patient will be asked to rate her pain as 0 corresponds ''no pain'' and 10 to the '' worst pain''
1 secondary outcome
Pain at the 30th minutes after the procedure evaluated by the 0-10 cm scale of VAS scoring system
Time frame: 30. Min
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 13 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Colposcopy
Not yet recruitingObservational study
Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit
Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms
RecruitingObservational study
Vaginal Wall Retraction Using VuSleeve
Adult Females
Not yet recruiting
Embodied Conversational Agents for CervicalCancer Screening Abnormalities
Cervical Cancer Screening
Recruiting
Improving Diagnostics in Cervical Dysplasia
Cervical Cancer
Not yet recruitingObservational study
VIA Versus Colposcopy
Cervical Intraepithelial Neoplasia (CIN), Cervicitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local lidocaine spray and forced coughing in people with Colposcopy, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 3 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 13 Mar 2018. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Pain during procedure evaluated by the 0-10 cm scale of Visual analog scale (VAS) scoring system (time frame: 0-1 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2018.