Pain Perception With Tenaculum Placement

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Study of Patient Pain Perception With Tenaculum Placement During In-office Procedures

Conditions
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Pain

Intervention / Treatment
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* Other: Cough method for placement of tenaculum
* Other: Slow Tenaculum Placement of tenaculum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Slow Tenaculum Placement<br>This group will have their tenaculum placed using the slow method | Other: Slow Tenaculum Placement of tenaculum<br>* The intervention in this arm is the placement of tenaculum via slow method<br>|
| Active Comparator: Cough Method<br>This group will have their tenaculum placed using the cough method | Other: Cough method for placement of tenaculum<br>* The intervention in this arm is the placement of tenaculum via cough method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain With Tenaculum Placement | Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain. | Directly after tenaculum placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Pain With Intrauterine Device Insertion | Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain. | Directly after intrauterine device is placed | 
| Provider Satisfaction With Tenaculum Placement | 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. | Directly after tenaculum is placed |