Back to resultsLidocaine Spray vs Coughing for Pain Relief During Colposcopy
Primary Purpose
Colposcopy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
local lidocaine spray
forced coughing
Sponsored by
About this trial
This is an interventional prevention trial for Colposcopy focused on measuring colposcopy, pain, coughing, anesthetic spray
Eligibility Criteria
Inclusion Criteria:
- Patients with age >18,
- Presence of cervix,
- Patients who need a diagnostic work up for abnormal cervical smear results.
Exclusion Criteria:
- Pregnancy,
- Presence of already known invasive cancer,
- Allergy to anesthetic agents.
Sites / Locations
- Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Placebo Comparator
Arm Label
colposcopic biopsy under local anesthetic sp
Patients underwent colposcopic biopsy under forced coughing
Arm Description
Outcomes
Primary Outcome Measures
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''
Secondary Outcome Measures
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''
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03100565
Brief Title
Lidocaine Spray vs Coughing for Pain Relief During Colposcopy
Official Title
Comparison of Lidocaine Spray With Forced Coughing in Pain Relief During Colposcopy Guided Cervical Biopsy Procedure: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 8, 2018 (Actual)
Study Completion Date
March 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colposcopy
Keywords
colposcopy, pain, coughing, anesthetic spray
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participants will be blinded to the methods used for pain relief.
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
colposcopic biopsy under local anesthetic sp
Arm Type
Placebo Comparator
Arm Title
Patients underwent colposcopic biopsy under forced coughing
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
local lidocaine spray
Intervention Description
The lidocaine spray will be introduced to the cervix just before the biopsy procedure
Intervention Type
Other
Intervention Name(s)
forced coughing
Intervention Description
The patients will be asked to forced coughing during the biopsy procedure
Primary Outcome Measure Information:
Title
Pain during procedure evaluated by the 0-10 cm scale of Visual analog scale (VAS) scoring system
Description
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''
Time Frame
0-1 min
Secondary Outcome Measure Information:
Title
Pain at the 30th minutes after the procedure evaluated by the 0-10 cm scale of VAS scoring system
Description
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''
Time Frame
30. Min
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with age >18,
Presence of cervix,
Patients who need a diagnostic work up for abnormal cervical smear results.
Exclusion Criteria:
Pregnancy,
Presence of already known invasive cancer,
Allergy to anesthetic agents.
Facility Information:
Facility Name
Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology
City
Van
ZIP/Postal Code
65000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lidocaine Spray vs Coughing for Pain Relief During Colposcopy
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