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Fast Versus Slow Tenaculum Placement

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ClinicalTrials.gov Identifier: NCT02716636
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Abbey Hardy-Fairbanks, University of Iowa

Tracking Information
First Submitted Date  ICMJE November 17, 2015
First Posted Date  ICMJE March 23, 2016
Last Update Posted Date March 21, 2018
Actual Study Start Date  ICMJE April 11, 2016
Actual Primary Completion Date March 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
Pain with tenaculum placement assessed using a VAS scale [ Time Frame: procedure ]
Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02716636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
  • Overall pain perception assessed using a VAS scale [ Time Frame: procedure ]
    Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.
  • Provider perception of patient pain assessed using a VAS scale [ Time Frame: procedure ]
    Providers will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fast Versus Slow Tenaculum Placement
Official Title  ICMJE Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial
Brief Summary The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.
Detailed Description IUD insertion and endometrial biopsies are commonly performed in office procedures that use a tenaculum to stabilize the cervix. Patient's often complain that tenaculum placement is one of the most uncomfortable parts of these procedures. Patient's who agree to be in the study will be randomized into one of two groups, either slow tenaculum placement or fast tenaculum placement. Throughout the procedure patient's will be asked to rate the amount of pain they are experiencing using a visual analog scale. The researchers will then compare the two groups. The providers will also rate what they perceived the patient's pain to be with the procedure.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • IUD Insertion Complication
  • Endometrial Diseases
Intervention  ICMJE Procedure: Slow placement of the tenaculum
Slow placement of the tenaculum on the cervix
Study Arms  ICMJE
  • No Intervention: Fast placement
    Placement of the tenaculum quickly and without avoiding ratchet
  • Experimental: Slow placement of the tenaculum
    Placement of the tenaculum over a 7-10 second time frame and not allowing the tenaculum to ratchet audibly.
    Intervention: Procedure: Slow placement of the tenaculum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2018)
121
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2016)
100
Actual Study Completion Date  ICMJE March 6, 2017
Actual Primary Completion Date March 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years old and older
  • Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy)
  • English speaking and able to consent

Exclusion Criteria:

  • Incarcerated
  • Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02716636
Other Study ID Numbers  ICMJE 201509756
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbey Hardy-Fairbanks, University of Iowa
Study Sponsor  ICMJE Abbey Hardy-Fairbanks
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abbey J Hardy-Fairbanks, MD University of Iowa
PRS Account University of Iowa
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP