Actively Recruiting
RCT of Pain Perception With Fast and Slow Tenaculum Application
Led by Women and Infants Hospital of Rhode Island · Updated on 2024-05-03
150
Participants Needed
1
Research Sites
322 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RCT of Pain Perception With Fast and Slow Tenaculum Application
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Plans for IUD insertion or endometrial biopsy
- Age between 18 and 49 years
- Have not taken analgesics or anxiolytics in the previous 24 hours
- Able and willing to give informed consent
You will not qualify if you...
- Do not speak English unless an interpreter is 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
Research Team
R
Rebecca Allen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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