RCT of Pain Perception With Fast and Slow Tenaculum Application

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute; Pain, Procedural
• Intervention / Treatment: Procedure: Speed of tenaculum application

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Allen, MD; Phone Number: 2724 401-274-1122; Email: RHAllen@wihri.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Recruiting
      • Women and Infants Hospital
      • Contact: Rebecca Allen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fast tenaculum application	Procedure: Speed of tenaculum application; Fast or slow closure of the tenaculum for application to the uterine cervix
Experimental: Slow tenaculum application	Procedure: Speed of tenaculum application; Fast or slow closure of the tenaculum for application to the uterine cervix

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Rebecca Allen, MD, Women & Infants Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Pain, Procedural
• Other Study ID Numbers: 1609832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No