Fast Versus Slow Tenaculum Placement

Endometrial Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716636
• Other study ID #: 201509756
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: March 19, 2018
• Start date: April 11, 2016
• Est. completion date: March 6, 2017

Study information

• Verified date: March 2018
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 6, 2017
• Est. primary completion date: March 6, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Diseases
• IUD Insertion Complication
• Uterine Diseases

Intervention

Procedure:
• Slow placement of the tenaculum
Slow placement of the tenaculum on the cervix

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbey Hardy-Fairbanks

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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