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Pain Perception With Tenaculum Placement

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Other: Cough method for placement of tenaculum Other: Slow Tenaculum Placement of tenaculum Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Patient Pain Perception With Tenaculum Placement During In-office Procedures
Actual Study Start Date : January 10, 2016
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Slow Tenaculum Placement
This group will have their tenaculum placed using the slow method
 Other: Slow Tenaculum Placement of tenaculum
The intervention in this arm is the placement of tenaculum via slow method
Active Comparator: Cough Method
This group will have their tenaculum placed using the cough method
 Other: Cough method for placement of tenaculum
The intervention in this arm is the placement of tenaculum via cough method


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol and Statistical Analysis Plan  [PDF] December 22, 2016

More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02969421    
Other Study ID Numbers: Pro00078232
First Posted: November 21, 2016    Key Record Dates
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019
Last Verified: December 2018