Pain Perception With Tenaculum Placement

Duke University

Status: Completed

Conditions: Pain

Treatments: Other: Slow Tenaculum Placement of tenaculum; Other: Cough method for placement of tenaculum

Study type: Interventional

Funder types: Other

Identifiers

NCT02969421

Pro00078232

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Slow Tenaculum Placement

Active Comparator group

Description:

This group will have their tenaculum placed using the slow method

Treatment:

Other: Slow Tenaculum Placement of tenaculum

Cough Method

Active Comparator group

Description:

This group will have their tenaculum placed using the cough method

Treatment:

Other: Cough method for placement of tenaculum