title: Effect of an atraumatic vulsellum versus a single-tooth tenaculum on pain perception during intrauterine device insertion: a randomized controlled trial.
abstract: BACKGROUND
  Intrauterine devices (IUDs) are used by only 5.6% of contraceptive users in the United States. One barrier to IUD uptake is fear of pain during insertion, particularly among nulliparous women. Many interventions to reduce pain during IUD insertion have proven unsuccessful. Comparisons of different tenaculae have not been previously reported.
  
  
  METHODS
  This was a single-blinded, randomized control trial of 80 women randomized to the use of a vulsellum or a single-tooth tenaculum during IUD insertion. The primary outcome was reported pain on a 100-mm visual analog scale at the time of vulsellum placement. Secondary outcomes included pain at other intervals during IUD insertion and bleeding from the tenaculum site. Pain scores were analyzed with a Mann-Whitney test because they were not normally distributed.
  
  
  RESULTS
  Pain scores at the time of single-tooth tenaculum (33.3 mm) and vulsellum (35.0 mm) placement were the same in both groups (p=0.58). It took longer to control bleeding in the single-tooth tenaculum versus the vulsellum group (1.1 vs. 0.4 min, p=0.001), although there was no statistically significant difference in the number of maneuvers required to control bleeding at the tenaculum site between the two groups. Preprocedure anxiety appeared to correlate with more pain during IUD insertion.
  
  
  CONCLUSIONS
  This is the first randomized trial comparing tenaculae. There was no difference in reported pain, but the vulsellum may be associated with less bleeding than a single-tooth tenaculum. Women with higher preprocedure anxiety may experience more pain during IUD insertion. Future research could investigate an anxiolytic's effect on pain during IUD insertion.
authors.affiliation: Mount Sinai Beth Israel Medical Center, 1st Avenue and 16th Street, New York, NY 10003. Electronic address: ndoty@chpnet.org.
authors.forename: Nora
authors.initials: N
authors.lastname: Doty
authors.affiliation: Mount Sinai Beth Israel Medical Center, 1st Avenue and 16th Street, New York, NY 10003. Electronic address: LMacIsaa@chpnet.org.
authors.forename: Laura
authors.initials: L
authors.lastname: MacIsaac
mesh_terms: D000328:Adult; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D007434:Intrauterine Devices; D010146:Pain / Q000209:etiology* / Q000523:psychology; D010147:Pain Measurement; D058748:Pain Perception; D019106:Postoperative Hemorrhage / Q000209:etiology; D016037:Single-Blind Method; D013525:Surgical Instruments / Q000009:adverse effects*
keywords: IUD; Intrauterine device; Pain; Vulsellum