Pain Perception With Tenaculum Placement

Pain Clinical Trial

Official title:

A Randomized Controlled Study of Patient Pain Perception With Tenaculum Placement During In-office Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969421
• Other study ID #: Pro00078232
• Status: Completed
• Phase: N/A
• Start date: January 10, 2016
• Est. completion date: February 23, 2017

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women ages 18 years and older

• Undergoing intrauterine device placement

• English or Spanish speaking

Exclusion Criteria:

• Primary language other than English or Spanish

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Cough method for placement of tenaculum
The intervention in this arm is the placement of tenaculum via cough method
• Slow Tenaculum Placement of tenaculum
The intervention in this arm is the placement of tenaculum via slow method

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain With Tenaculum Placement	Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.	Directly after tenaculum placement
Secondary	Overall Pain With Intrauterine Device Insertion	Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.	Directly after intrauterine device is placed
Secondary	Provider Satisfaction With Tenaculum Placement	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.	Directly after tenaculum is placed