RCT of Pain Perception With Fast and Slow Tenaculum Application

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Women and Infants Hospital
Providence, Rhode Island 02905
Contact:
Rebecca Allen

More Details

Status
Recruiting
Sponsor
Women and Infants Hospital of Rhode Island

Study Contact

Rebecca Allen, MD
401-274-1122
RHAllen@wihri.org

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.