RCT of Pain Perception With Fast and Slow Tenaculum Application

Description

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

Pain, Acute, Pain, Procedural

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

RCT of Pain Perception With Fast and Slow Tenaculum Application

Condition
Pain, Acute
Intervention / Treatment

-

Contacts and Locations

Providence

Women and Infants Hospital, Providence, Rhode Island, United States, 02905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Women and Infants Hospital of Rhode Island,

Rebecca Allen, MD, PRINCIPAL_INVESTIGATOR, Women & Infants Hospital

Study Record Dates

2026-12