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RCT of Pain Perception With Fast and Slow Tenaculum Application

RecruitingNAAges 18 Years - anyFemaleWomen and Infants Hospital of Rhode Island
NCT05458037 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. plans for IUD insertion or endometrial biopsy; 2. 18 to 49 years of age; 3. not taken analgesics or anxiolytics in the previous 24 hours; 4. the ability and are willing to give informed consent. Exclusion Criteria: 1. Do not speak English unless interpreter present; 2. Taken any narcotic or opiate medication in the last 24 hours. 3. Taken any recreational or illegal drugs in the last 24 hours, such as marijuana, heroin, cocaine, crack, or methamphetamines. 4. Taken any anti-anxiety medication or drug in the last 24 hours. 5. Taken any NSAIDS or Tylenol in the last 12 hours.
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What it tests

  • Speed of tenaculum application
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Where

1 site
Women and Infants Hospital
Providence, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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