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OpenTrials
Completed

NCT Number: NCT02969421

Pain Perception With Tenaculum Placement

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cough method for placement of tenaculum

Other

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

Slow Tenaculum Placement of tenaculum

Other

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

Primary outcomes

  1. Pain With Tenaculum Placement

    Time frame: 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 outcomes

  1. Overall Pain With Intrauterine Device Insertion

    Time frame: 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.

  2. Provider Satisfaction With Tenaculum Placement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2016
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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