Fast Versus Slow Tenaculum Placement

• Sponsor: Abbey Hardy-Fairbanks (Other)
• Overall Status: Completed
• CT.gov ID: NCT02716636
• Collaborator: (none)
• Enrollment: 121
• Arms: 2
• Actual Duration (Months): 10.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
IUD Insertion Complication; Endometrial Diseases	Procedure: Slow placement of the tenaculum	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial
• Actual Study Start Date: Apr 11, 2016
• Actual Primary Completion Date: Mar 6, 2017
• Actual Study Completion Date: Mar 6, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain with tenaculum placement assessed using a VAS scale [procedure]

   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

1. Overall pain perception assessed using a VAS scale [procedure]

   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.

2. Provider perception of patient pain assessed using a VAS scale [procedure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Abbey Hardy-Fairbanks

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbey Hardy-Fairbanks, Associate Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT02716636
• Other Study ID Numbers: 201509756
• First Posted: Mar 23, 2016
• Last Update Posted: Mar 21, 2018
• Last Verified: Mar 1, 2018

• Additional relevant MeSH terms: Uterine Diseases

Study Results

No Results Posted as of Mar 21, 2018