RCT of Pain Perception With Fast and Slow Tenaculum Application

Study Overview
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Brief Summary
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This project will be a randomized controlled trial (RCT) measuring pain perception with two different tenaculum placement techniques on the uterine cervix. A tenaculum is an instrument used to hold the cervix (the opening to the uterus or womb) in place. The trial will measure pain perception with a Visual Analog Scale (VAS) from 0 to 100 mm for two different tenaculum placement techniques, fast and slow closure on the uterine cervix. The main objective of this study is to determine if there is a difference in pain perception with fast compared to slow tenaculum placement techniques on the uterine cervix. We hypothesize that the slow technique will be perceived as less painful for subjects as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). Subsidiary objectives include describing overall pain levels during the procedure.

Detailed Description
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In order to detect a 15 mm difference on the VAS with two-sided 5% alpha and 80% power and a standard deviation of 33 mm (based on prior studies), a total of 71 subjects per group are required. We aim to recruit 75 subjects per arm in order to account for possible drop out.

Official Title
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A Randomized Controlled Trial of Pain Perception With Fast and Slow Tenaculum Application to the Uterine Cervix

Conditions
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Pain, Acute, Pain, Procedural

Intervention / Treatment
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* Procedure: Speed of tenaculum application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: plans for IUD insertion or endometrial biopsy; 18 to 49 years of age; not taken analgesics or anxiolytics in the previous 24 hours; the ability and are willing to give informed consent. Exclusion Criteria: Do not speak English unless interpreter present; Taken any narcotic or opiate medication in the last 24 hours. Taken any recreational or illegal drugs in the last 24 hours, such as marijuana, heroin, cocaine, crack, or methamphetamines. Taken any anti-anxiety medication or drug in the last 24 hours. Taken any NSAIDS or Tylenol in the last 12 hours.

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 |
| --- | --- |
| Experimental: Fast tenaculum application<br> | Procedure: Speed of tenaculum application<br>* Fast or slow closure of the tenaculum for application to the uterine cervix<br>|
| Experimental: Slow tenaculum application<br> | Procedure: Speed of tenaculum application<br>* Fast or slow closure of the tenaculum for application to the uterine cervix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception with tenaculum application | Pain scores will be determined using the Visual Analog Scale (VAS) from 0 to 100 mm. | during procedure |