NCT05458037

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Sep 2020Dec 2026

Study Start

First participant enrolled

September 29, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

6.2 years

First QC Date

July 11, 2022

Last Update Submit

May 1, 2024

Conditions

Pain, AcutePain, Procedural

Outcome Measures

Primary Outcomes (1)

  • Pain perception with tenaculum application

    Pain scores will be determined using the Visual Analog Scale (VAS) from 0 to 100 mm.

    during procedure

Study Arms (2)

Fast tenaculum application

EXPERIMENTAL
Procedure: Speed of tenaculum application

Slow tenaculum application

EXPERIMENTAL
Procedure: Speed of tenaculum application

Interventions

Speed of tenaculum applicationPROCEDURE

Fast or slow closure of the tenaculum for application to the uterine cervix

Fast tenaculum applicationSlow tenaculum application

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • plans for IUD insertion or endometrial biopsy;
  • to 49 years of age;
  • not taken analgesics or anxiolytics in the previous 24 hours;
  • the ability and are willing to give informed consent.

You may not qualify if:

  • Do not speak English unless interpreter present;
  • Taken any narcotic or opiate medication in the last 24 hours.
  • Taken any recreational or illegal drugs in the last 24 hours, such as marijuana, heroin, cocaine, crack, or methamphetamines.
  • Taken any anti-anxiety medication or drug in the last 24 hours.
  • Taken any NSAIDS or Tylenol in the last 12 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

RECRUITING

Related 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.

    PMID: 24286993BACKGROUND

  • 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.

    PMID: 11733293BACKGROUND

  • 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.

    PMID: 26007292BACKGROUND

  • 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.

    PMID: 26894801BACKGROUND

  • 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.

    PMID: 31666302BACKGROUND

MeSH Terms

Conditions

Acute PainPain, Procedural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rebecca Allen, MD

    Women & Infants Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Allen, MD

CONTACT

401-274-1122RHAllen@wihri.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 14, 2022

Study Start

September 29, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)