Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain Perception With Tenaculum Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02969421
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE November 17, 2016
First Posted Date  ICMJE November 21, 2016
Results First Submitted Date  ICMJE May 14, 2018
Results First Posted Date  ICMJE March 18, 2019
Last Update Posted Date March 18, 2019
Actual Study Start Date  ICMJE January 10, 2016
Actual Primary Completion Date February 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
Pain With Tenaculum Placement [ Time Frame: Directly after tenaculum placement ]
Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
Pain With Tenaculum Placement [ Time Frame: Directly after tenaculum placement ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Overall Pain With Intrauterine Device Insertion [ Time Frame: Directly after intrauterine device is placed ]
    Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
  • Provider Satisfaction With Tenaculum Placement [ Time Frame: Directly after tenaculum is placed ]
    Measured using Likert-type 5 point satisfaction scale dichotomized to optimal (Likert score = 4 or 5) vs suboptimal (Likert score = 1, 2, 3). Reported is the number of participants with optimal grasp.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
  • Overall pain with IUD insertion [ Time Frame: Directly after IUD is placed ]
  • Provider Satisfaction With Tenaculum Placement [ Time Frame: Directuly after tenaculm is placed ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Perception With Tenaculum Placement
Official Title  ICMJE A Randomized Controlled Study of Patient Pain Perception With Tenaculum Placement During In-office Procedures
Brief Summary Randomized controlled trial that compares methods of tenaculum placement during intrauterine device insertion and their effect on pain. The two methods being compared are slow tenaculum placement versus tenaculum placement at time of cough. Subjects will be asked to rate their pain using visual analog scale. Primary outcome measured is pain at time of tenaculum placement. Secondary outcomes are overall pain with intrauterine device insertion and provider satisfaction with tenaculum placement.
Detailed Description The two commonly described strategies for tenaculum placement, slow versus having the patient cough while the tenaculum is placed are utilized by providers based on preference and/or their previous training. There is no published study that compares these methods to one another. The investigators aim to compare these strategies, slow tenaculum placement versus the cough method, and their effects on pain at time of placement. 96 subjects will be randomized to each method. The subject will be asked to rate their pain using a 100-mm visual analog scale after speculum placement, after tenaculum is placed, and after completion of the procedure. The provider will be asked to rate their satisfaction with tenaculum placement on a Likert-type 5 point satisfaction scale. 1: not at all satisfied, 2: slightly satisfied, 3: moderately satisfied, 4: very satisfied, 5: extremely satisfied. All data to be collected using REDCap database.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Other: Cough method for placement of tenaculum
    The intervention in this arm is the placement of tenaculum via cough method
  • Other: Slow Tenaculum Placement of tenaculum
    The intervention in this arm is the placement of tenaculum via slow method
Study Arms  ICMJE
  • Active Comparator: Slow Tenaculum Placement
    This group will have their tenaculum placed using the slow method
    Intervention: Other: Slow Tenaculum Placement of tenaculum
  • Active Comparator: Cough Method
    This group will have their tenaculum placed using the cough method
    Intervention: Other: Cough method for placement of 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: April 17, 2017)
66
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2016)
96
Actual Study Completion Date  ICMJE February 23, 2017
Actual Primary Completion Date February 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women ages 18 years and older
  • Undergoing intrauterine device placement
  • English or Spanish speaking

Exclusion Criteria:

  • Primary language other than English or Spanish
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02969421
Other Study ID Numbers  ICMJE Pro00078232
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date December 2018

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