Fast Versus Slow Tenaculum Placement

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

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

Study Overview

• Status: Completed
• Conditions: IUD Insertion Complication; Endometrial Diseases
• Intervention / Treatment: Procedure: Slow placement of the tenaculum

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Fast placement; Placement of the tenaculum quickly and without avoiding ratchet
Experimental: Slow placement of the tenaculum; 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; Slow placement of the tenaculum on the cervix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	procedure
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.	procedure

Collaborators and Investigators

• Sponsor: Abbey Hardy-Fairbanks
• Investigators: Principal Investigator: Abbey J Hardy-Fairbanks, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2016
• Primary Completion (Actual): March 6, 2017
• Study Completion (Actual): March 6, 2017

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases
• Other Study ID Numbers: 201509756