Tubal sterilization
Conditions
Interventions
Intervention group: comprised of 43 volunteers who received a 10 mg tablet of diazepam thirty minutes prior to the initiation of the device insertion procedure.
Control group: 39 volunteers, who recei
Drug
Device
Procedure/surgery
HP3.073.433.101
Sponsors
Hospital das Clínicas de Ribeirão Preto - HCRP
Hospital das Clínicas de Ribeirão Preto - HCRP
Eligibility
Sex/Gender
Female
Age
25 Years to 45 Years
Inclusion criteria
Inclusion criteria: 82 women were recruited, after being evaluated in the Contraceptive Outpatient Clinic and released for such procedure, having fulfilled all the criteria of Law 9.263 (Law on Family Planning), 1996 (article 226 of the Federal Constitution).
Exclusion criteria
Exclusion criteria: Minimum age of 25 years and maximum of 45 years; women with an allergic reaction to the nickel component in the devices; women who are pregnant or in the immediate puerperal period; chronic use of medications that could interfere with the pain threshold; uterine malformation; single or bilateral anterior tubal ligation or surgery; signs and or symptoms of vaginal or cervical infection;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate in patients submitted to tubal sterilization by hysteroscopy if the use of diazepam prior to the procedure facilitates its insertion or not, through the evaluation of the inserting physician in an easy, difficult variable or if there was a failure in the placement of the devices through the Chi-Square test and divided into three categories: 0 for easy placement, 1 for difficult placement, and therefore for resistance, and 2 for those in which placement failed. We also assessed the agreement between the two sides of the tubas and the ease of insertion of the devices through Kappa, in order to exclude the bias of the same patient having different evaluations between the two sides. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of the use of diazepam in patients submitted to tubal sterilization by hysteroscopy: 1. In pain reported by the patient immediately after insertion performed by the International Association for the Study of Pain (IASP) 2. At the time of insertion performed by wall-mounted stopwatch in the procedure room | — |
Countries
Brazil
Contacts
Public ContactDepartamento de Ginecologia e Obstetrícia HCRP
Hospital das Clínicas de Ribeirão Preto - HCRP
Outcome results
None listed