Pain Perception With Tenaculum Placement

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Slow Tenaculum Placement of tenaculum; Other: Cough method for placement of tenaculum

• Registration Number: NCT02969421
• Lead Sponsor: Duke University

Brief Summary

Randomized controlled trial that compares methods of tenaculum placement during intrauterine device insertion and their effect on pain. The two methods being compared are slow tenaculum placement versus tenaculum placement at time of cough. Subjects will be asked to rate their pain using visual analog scale. Primary outcome measured is pain at time of tenaculum placement. Secondary outcomes are overall pain with intrauterine device insertion and provider satisfaction with tenaculum placement.

Detailed Description

The two commonly described strategies for tenaculum placement, slow versus having the patient cough while the tenaculum is placed are utilized by providers based on preference and/or their previous training. There is no published study that compares these methods to one another. The investigators aim to compare these strategies, slow tenaculum placement versus the cough method, and their effects on pain at time of placement. 96 subjects will be randomized to each method. The subject will be asked to rate their pain using a 100-mm visual analog scale after speculum placement, after tenaculum is placed, and after completion of the procedure. The provider will be asked to rate their satisfaction with tenaculum placement on a Likert-type 5 point satisfaction scale. 1: not at all satisfied, 2: slightly satisfied, 3: moderately satisfied, 4: very satisfied, 5: extremely satisfied. All data to be collected using REDCap database.

Study Timeline

• Study Start: 2016-01-10
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-21
• Primary Completion: 2017-02-23
• Study Completion: 2017-02-23
• Results First Submitted: 2018-05-14
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-06
• Last Update Submitted: 2018-12-06
• Results First Posted: 2019-03-18
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• Women ages 18 years and older
• Undergoing intrauterine device placement
• English or Spanish speaking

Read More

Exclusion Criteria

• Primary language other than English or Spanish

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Slow Tenaculum Placement	Slow Tenaculum Placement of tenaculum	This group will have their tenaculum placed using the slow method
Cough Method	Cough method for placement of tenaculum	This group will have their tenaculum placed using the cough method

Primary Outcome Measures

Name	Time	Method
Pain With Tenaculum Placement	Directly after tenaculum placement	Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.

Secondary Outcome Measures

Name	Time	Method
Overall Pain With Intrauterine Device Insertion	Directly after intrauterine device is placed	Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
Provider Satisfaction With Tenaculum Placement	Directly after tenaculum is placed	Measured using Likert-type 5 point satisfaction scale dichotomized to optimal (Likert score = 4 or 5) vs suboptimal (Likert score = 1, 2, 3). Reported is the number of participants with optimal grasp.