RCT of Pain Perception With Fast and Slow Tenaculum Application

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458037
• Other study ID #: 1609832
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Women and Infants Hospital of Rhode Island
• Contact: Rebecca Allen, MD
• Phone: 401-274-1122
• Email: RHAllen[@]wihri.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Pain, Procedural

Intervention

Procedure:
• Speed of tenaculum application
Fast or slow closure of the tenaculum for application to the uterine cervix

Locations

Country	Name	City	State
United States	Women and Infants Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (5)

Allen RH, Micks E, Edelman A. Pain relief for obstetric and gynecologic ambulatory procedures. Obstet Gynecol Clin North Am. 2013 Dec;40(4):625-45. doi: 10.1016/j.ogc.2013.08.005. — View Citation

Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x. — View Citation

Doty N, MacIsaac L. Effect of an atraumatic vulsellum versus a single-tooth tenaculum on pain perception during intrauterine device insertion: a randomized controlled trial. Contraception. 2015 Dec;92(6):567-71. doi: 10.1016/j.contraception.2015.05.009. Epub 2015 May 22. — View Citation

Ireland LD, Allen RH. Pain Management for Gynecologic Procedures in the Office. Obstet Gynecol Surv. 2016 Feb;71(2):89-98. doi: 10.1097/OGX.0000000000000272. — View Citation

Lambert T, Truong T, Gray B. Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial. BMJ Sex Reprod Health. 2020 Apr;46(2):126-131. doi: 10.1136/bmjsrh-2019-200376. Epub 2019 Oct 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain perception with tenaculum application	Pain scores will be determined using the Visual Analog Scale (VAS) from 0 to 100 mm.	during procedure