Pain Perception With Tenaculum Placement

NCT ID: NCT02969421

Last Updated: 2019-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-10
• Study Completion Date: 2017-02-23

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Slow Tenaculum Placement

This group will have their tenaculum placed using the slow method

Group Type: ACTIVE_COMPARATOR

Slow Tenaculum Placement of tenaculum

Intervention Type: OTHER

The intervention in this arm is the placement of tenaculum via slow method

Cough Method

This group will have their tenaculum placed using the cough method

Group Type: ACTIVE_COMPARATOR

Cough method for placement of tenaculum

Intervention Type: OTHER

The intervention in this arm is the placement of tenaculum via cough method

Interventions

Cough method for placement of tenaculum

The intervention in this arm is the placement of tenaculum via cough method

Intervention Type: OTHER

Slow Tenaculum Placement of tenaculum

The intervention in this arm is the placement of tenaculum via slow method

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Lambert T, Truong T, Gray B. Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial. BMJ Sex Reprod Health. 2020 Apr;46(2):126-131. doi: 10.1136/bmjsrh-2019-200376. Epub 2019 Oct 30.

Reference Type: DERIVED

PMID: 31666302 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00078232

Identifier Type: -

Identifier Source: org_study_id