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Fast Versus Slow Tenaculum Placement

Primary Purpose

IUD Insertion Complication, Endometrial Diseases

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Slow placement of the tenaculum

About this trial

This is an interventional treatment trial for IUD Insertion Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Fast placement

Slow placement of the tenaculum

Arm Description

Placement of the tenaculum quickly and without avoiding ratchet

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall pain perception 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.

Provider perception of patient pain assessed using a VAS scale

Providers 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.

Full Information

NCT ID

NCT02716636

First Posted

November 17, 2015

Last Updated

March 19, 2018

Sponsor

Abbey Hardy-Fairbanks

1. Study Identification

Unique Protocol Identification Number

NCT02716636

Brief Title

Fast Versus Slow Tenaculum Placement

Official Title

Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

April 11, 2016 (Actual)

Primary Completion Date

March 6, 2017 (Actual)

Study Completion Date

March 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Abbey Hardy-Fairbanks

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

IUD insertion and endometrial biopsies are commonly performed in office procedures that use a tenaculum to stabilize the cervix. Patient's often complain that tenaculum placement is one of the most uncomfortable parts of these procedures. Patient's who agree to be in the study will be randomized into one of two groups, either slow tenaculum placement or fast tenaculum placement. Throughout the procedure patient's will be asked to rate the amount of pain they are experiencing using a visual analog scale. The researchers will then compare the two groups. The providers will also rate what they perceived the patient's pain to be with the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IUD Insertion Complication, Endometrial Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fast placement

Arm Type

No Intervention

Arm Description

Placement of the tenaculum quickly and without avoiding ratchet

Arm Title

Slow placement of the tenaculum

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Slow placement of the tenaculum

Intervention Description

Slow placement of the tenaculum on the cervix

Primary Outcome Measure Information:

Title

Pain with tenaculum placement assessed using a VAS scale

Description

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.

Time Frame

procedure

Secondary Outcome Measure Information:

Title

Overall pain perception assessed using a VAS scale

Description

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.

Time Frame

procedure

Title

Provider perception of patient pain assessed using a VAS scale

Description

Providers 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.

Time Frame

procedure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years old and older Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy) English speaking and able to consent Exclusion Criteria: Incarcerated Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abbey J Hardy-Fairbanks, MD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Fast Versus Slow Tenaculum Placement

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