NCT02716636

Brief Summary

The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Status
completed

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

First Submitted

Initial submission to the registry

November 17, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

April 11, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2017

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

November 17, 2015

Last Update Submit

March 19, 2018

Conditions

IUD Insertion ComplicationEndometrial Diseases

Outcome Measures

Primary Outcomes (1)

  • Pain with tenaculum placement assessed using a VAS scale

    Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.

    procedure

Secondary Outcomes (2)

  • Overall pain perception assessed using a VAS scale

    procedure

  • Provider perception of patient pain assessed using a VAS scale

    procedure

Study Arms (2)

Fast placement

NO INTERVENTION

Placement of the tenaculum quickly and without avoiding ratchet

Slow placement of the tenaculum

EXPERIMENTAL

Placement of the tenaculum over a 7-10 second time frame and not allowing the tenaculum to ratchet audibly.

Procedure: Slow placement of the tenaculum

Interventions

Slow placement of the tenaculumPROCEDURE

Slow placement of the tenaculum on the cervix

Slow placement of the tenaculum

Eligibility Criteria

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

You may qualify if:

  • years old and older
  • Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy)
  • English speaking and able to consent

You may not qualify if:

  • Incarcerated
  • Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Abbey J Hardy-Fairbanks, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

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 INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 17, 2015

First Posted

March 23, 2016

Study Start

April 11, 2016

Primary Completion

March 6, 2017

Study Completion

March 6, 2017

Last Updated

March 21, 2018

Record last verified: 2018-03