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NCT02969421

Pain Perception With Tenaculum Placement

Completed NA Results posted Last updated 18 March 2019
What this trial tests

NA trial testing Cough method for placement of tenaculum in Pain in 66 participants. Completed in 23 February 2017.

Timeline
10 January 2016
Primary endpoint
23 February 2017
23 February 2017

Quick facts

Lead sponsorDuke University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment66
Start date10 January 2016
Primary completion23 February 2017
Estimated completion23 February 2017

Drugs / interventions tested

Conditions studied

Sponsor

Duke University

Who can join

Adults 18 to 55, female only, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain With Tenaculum Placement Primary · 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.

GroupValue95% CI
Slow Tenaculum Placement4421 – 63
Cough Method3219 – 54
Overall Pain With Intrauterine Device Insertion Secondary · 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.

GroupValue95% CI
Slow Tenaculum Placement6248 – 84
Cough Method5432 – 71
Provider Satisfaction With Tenaculum Placement Secondary · 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.

GroupValue95% CI
Slow Tenaculum Placement26
Cough Method27

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial.
    Lambert T, Truong T, Gray B. · · 2020 · cited 8× · PMID 31666302 · DOI 10.1136/bmjsrh-2019-200376

Verify or expand the search:

Other recruiting trials for Pain

Currently open trials in the same condition.

Other Duke University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02969421.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing