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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

Brief Summary:
The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.

Condition or disease Intervention/treatment Phase
IUD Insertion Complication Endometrial Diseases Procedure: Slow placement of the tenaculum Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial
Actual Study Start Date : April 11, 2016
Actual Primary Completion Date : March 6, 2017
Actual Study Completion Date : March 6, 2017

Arm Intervention/treatment
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.
Procedure: Slow placement of the tenaculum
Slow placement of the tenaculum on the cervix




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716636


Sponsors and Collaborators
Abbey Hardy-Fairbanks
Investigators
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Principal Investigator: Abbey J Hardy-Fairbanks, MD University of Iowa

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Responsible Party: Abbey Hardy-Fairbanks, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02716636     History of Changes
Other Study ID Numbers: 201509756
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Uterine Diseases
Genital Diseases, Female