Comparing pain perception with fast and slow tenaculum application techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project is a randomized controlled trial measuring pain perception during two different techniques of tenaculum placement on the uterine cervix. The study will utilize a Visual Analog Scale (VAS) to assess pain levels from 0 to 100 mm for both fast and slow application methods. The primary goal is to determine if the slow technique results in less pain perception compared to the fast technique. A total of 150 subjects will be recruited, with 75 in each group, to ensure adequate power for detecting significant differences in pain levels.

Why it matters

Who can join: the full rules

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.

Where it's running

• Women and Infants Hospital
  Providence, Rhode Island, United States Recruiting

Study contacts

• Principal investigator: Rebecca Allen, MD — Women & Infants Hospital
• Study coordinator: Rebecca Allen, MD
• Email: RHAllen@wihri.org
• Phone: 401-274-1122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.