RECRUITING

RCT of Pain Perception With Fast and Slow Tenaculum Application

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-09-29
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05458037

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. plans for IUD insertion or endometrial biopsy;
  2. 2. 18 to 49 years of age;
  3. 3. not taken analgesics or anxiolytics in the previous 24 hours;
  4. 4. the ability and are willing to give informed consent.
  1. 1. Do not speak English unless interpreter present;
  2. 2. Taken any narcotic or opiate medication in the last 24 hours.
  3. 3. Taken any recreational or illegal drugs in the last 24 hours, such as marijuana, heroin, cocaine, crack, or methamphetamines.
  4. 4. Taken any anti-anxiety medication or drug in the last 24 hours.
  5. 5. Taken any NSAIDS or Tylenol in the last 12 hours.

Contacts and Locations

Study Contact

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

Principal Investigator

Rebecca Allen, MD
PRINCIPAL_INVESTIGATOR
Women & Infants Hospital

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Women and Infants Hospital of Rhode Island

  • Rebecca Allen, MD, PRINCIPAL_INVESTIGATOR, Women & Infants Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-29
Study Completion Date2026-12

Study Record Updates

Study Start Date2020-09-29
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Pain, Acute
  • Pain, Procedural