Fast Versus Slow Tenaculum Placement

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

Detailed Description
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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.

Official Title
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Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial

Conditions
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IUD Insertion Complication, Endometrial Diseases

Intervention / Treatment
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* Procedure: Slow placement of the tenaculum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Fast placement<br>Placement of the tenaculum quickly and without avoiding ratchet | |
| Experimental: Slow placement of the tenaculum<br>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<br>* Slow placement of the tenaculum on the cervix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain with tenaculum placement assessed using a VAS scale | 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. | procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall pain perception assessed using a VAS scale | 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. | procedure | 
| Provider perception of patient pain assessed using a VAS scale | 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. | procedure |