Comparing pain perception with fast and slow tenaculum application techniques
A Randomized Controlled Trial of Pain Perception With Fast and Slow Tenaculum Application to the Uterine Cervix
This study is testing whether placing a tenaculum slowly on the cervix causes less pain than doing it quickly for women undergoing this procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05458037 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 49 who are planning for IUD insertion or endometrial biopsy and can provide informed consent.
Not a fit: Patients who have taken analgesics, anxiolytics, or certain recreational drugs within specified time frames may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques during gynecological procedures.
How similar studies have performed: Previous studies have explored pain perception in similar contexts, but this specific comparison of tenaculum application techniques is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Providence, Rhode Island
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.