Treatment Prior to Injection and Biopsy of the Vulva
Primary Purpose
Vulvar Diseases, Anesthesia, Anesthesia, Local
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ice Pre-treatment
Room Temperature Water Pre-treatment
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Diseases focused on measuring vulvar biopsy, ice, anesthesia, pain, vulva
Eligibility Criteria
Inclusion Criteria:
- Female
- 18 years of age or older
- Undergoing vulva biopsy during clinic visit
- Willing and able to comply with study protocol
- Able to understand and provide informed consent
Exclusion Criteria:
- Inability to provide informed consent
Sites / Locations
- Missouri Ob/Gyn Associated
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ice Pre-treatment
Room Temperature Water Pre-Treatment
Arm Description
Participants will hold an exam glove filled with ice to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection.
Participants will hold an exam glove filled with room temperature water to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection.
Outcomes
Primary Outcome Measures
Post-injection Pain Score
Patient's self-reported visual analogue pain scale (100 millimeter) after injection of local anesthetic. Range from 0 to 100 mm, with 0 being least amount of pain and 100 being the most amount of pain.
Secondary Outcome Measures
Post-procedure satisfaction score
Patient's self-reported visual analogue scale (100 millimeter) for satisfaction with the procedure. Range form 0mm to 100mm with 0 being the least satisfied and 100 being the most satisfied.
Post-procedure anxiety score
Patient's self-reported visual analogue scale (100 millimeter) score for anxiety level about having another vulvar biopsy in the future. Range from 0mm to 100mm, with 0 being the least anxious and 100 being the most anxious about a future procedure.
Post-procedure pain control score
Patient's self-reported visual analogue scale (100 millimeter) for satisfaction with pain control during procedure. Range from 0mm to 100mm with 0 being the least satisfied with pain control and 100mm being the most satisfied with pain control.
Post-biopsy pain score
Patient's self-reports visual analogue pain scale (100 millimeter) score immediately after biopsy. Range from 0mm to 100mm, with 0 being the the least pain and 100 being the most pain.
Full Information
NCT ID
NCT03444727
First Posted
February 19, 2018
Last Updated
March 27, 2022
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03444727
Brief Title
Treatment Prior to Injection and Biopsy of the Vulva
Official Title
Treatment Prior to Injection and Biopsy of the Vulva
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Not enough enrollment
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will compare pre-treatment with ice prior to injection of local anesthetic for vulvar biopsy to no pre-treatment and evaluate pain levels and patient satisfaction with the procedure.
Detailed Description
To diagnose skin conditions of the vulva and determine appropriate treatment, a biopsy is often taken as an outpatient procedure. Prior to biopsy, the skin is cleansed and injected with a numbing solution. These injections can be quite painful in this sensitive area.
Ice has been used as topical anesthesia in a number of sites, including the cornea, the skin, and particularly in the mouth prior to anesthetic injections. However, there is no evidence for using ice anesthesia prior to injections of the vulvar tissues.
The purpose of this study is to evaluate the efficacy of using ice as pre-treatment prior to the injection of local anesthetic for vulvar biopsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Diseases, Anesthesia, Anesthesia, Local
Keywords
vulvar biopsy, ice, anesthesia, pain, vulva
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to either pre-treatment with ice inside a sterile glove or with room-temperature water inside an exam glove.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ice Pre-treatment
Arm Type
Experimental
Arm Description
Participants will hold an exam glove filled with ice to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection.
Arm Title
Room Temperature Water Pre-Treatment
Arm Type
Placebo Comparator
Arm Description
Participants will hold an exam glove filled with room temperature water to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection.
Intervention Type
Other
Intervention Name(s)
Ice Pre-treatment
Intervention Description
Topical application of ice prior to local anesthetic injection.
Intervention Type
Other
Intervention Name(s)
Room Temperature Water Pre-treatment
Intervention Description
Topical application of room-temperature water prior to local anesthetic injection.
Primary Outcome Measure Information:
Title
Post-injection Pain Score
Description
Patient's self-reported visual analogue pain scale (100 millimeter) after injection of local anesthetic. Range from 0 to 100 mm, with 0 being least amount of pain and 100 being the most amount of pain.
Time Frame
Immediately after local anesthetic injection
Secondary Outcome Measure Information:
Title
Post-procedure satisfaction score
Description
Patient's self-reported visual analogue scale (100 millimeter) for satisfaction with the procedure. Range form 0mm to 100mm with 0 being the least satisfied and 100 being the most satisfied.
Time Frame
Immediately after procedure
Title
Post-procedure anxiety score
Description
Patient's self-reported visual analogue scale (100 millimeter) score for anxiety level about having another vulvar biopsy in the future. Range from 0mm to 100mm, with 0 being the least anxious and 100 being the most anxious about a future procedure.
Time Frame
Immediately after procedure
Title
Post-procedure pain control score
Description
Patient's self-reported visual analogue scale (100 millimeter) for satisfaction with pain control during procedure. Range from 0mm to 100mm with 0 being the least satisfied with pain control and 100mm being the most satisfied with pain control.
Time Frame
Immediately after procedure
Title
Post-biopsy pain score
Description
Patient's self-reports visual analogue pain scale (100 millimeter) score immediately after biopsy. Range from 0mm to 100mm, with 0 being the the least pain and 100 being the most pain.
Time Frame
Immediately after procedure.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
18 years of age or older
Undergoing vulva biopsy during clinic visit
Willing and able to comply with study protocol
Able to understand and provide informed consent
Exclusion Criteria:
Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Barnes, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Missouri Ob/Gyn Associated
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11359502
Citation
Kuwahara RT, Skinner RB. Emla versus ice as a topical anesthetic. Dermatol Surg. 2001 May;27(5):495-6. doi: 10.1046/j.1524-4725.2001.00343.x.
Results Reference
background
PubMed Identifier
12561049
Citation
Chan HH, Lam LK, Wong DS, Wei WI. Role of skin cooling in improving patient tolerability of Q-switched Alexandrite (QS Alex) laser in nevus of Ota treatment. Lasers Surg Med. 2003;32(2):148-51. doi: 10.1002/lsm.10112.
Results Reference
background
PubMed Identifier
16754218
Citation
Goel S, Chang B, Bhan K, El-Hindy N, Kolli S. "Cryoanalgesic preparation" before local anaesthetic injection for lid surgery. Orbit. 2006 Jun;25(2):107-10. doi: 10.1080/01676830600675392.
Results Reference
background
PubMed Identifier
17567343
Citation
Leff DR, Nortley M, Dang V, Bhutiani RP. The effect of local cooling on pain perception during infiltration of local anaesthetic agents, a prospective randomised controlled trial. Anaesthesia. 2007 Jul;62(7):677-82. doi: 10.1111/j.1365-2044.2007.05056.x.
Results Reference
background
PubMed Identifier
23617804
Citation
Dixit S, Lowe P, Fischer G, Lim A. Ice anaesthesia in procedural dermatology. Australas J Dermatol. 2013 Nov;54(4):273-6. doi: 10.1111/ajd.12057. Epub 2013 Apr 26.
Results Reference
background
PubMed Identifier
24379869
Citation
Ghaderi F, Banakar S, Rostami S. Effect of pre-cooling injection site on pain perception in pediatric dentistry: "A randomized clinical trial". Dent Res J (Isfahan). 2013 Nov;10(6):790-4.
Results Reference
background
PubMed Identifier
24945871
Citation
Lindsell LB, Miller DM, Brown JL. Use of topical ice for local anesthesia for intravitreal injections. JAMA Ophthalmol. 2014 Aug;132(8):1010-1. doi: 10.1001/jamaophthalmol.2014.1397. No abstract available.
Results Reference
background
PubMed Identifier
26379379
Citation
Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.
Results Reference
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PubMed Identifier
26957683
Citation
Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.
Results Reference
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PubMed Identifier
28559708
Citation
Bhadauria US, Dasar PL, Sandesh N, Mishra P, Godha S. Effect of injection site pre-cooling on pain perception in patients attending a dental camp at Life Line Express: a split mouth interventional study. Clujul Med. 2017;90(2):220-225. doi: 10.15386/cjmed-694. Epub 2017 Apr 25.
Results Reference
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Treatment Prior to Injection and Biopsy of the Vulva
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