Contraception
Conditions
Keywords
intrauterine device, contraceptive method, direct technique, torpedo technique, verbal numeric scale
Brief summary
Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years depending on the model) and among the most effective. However, there are many obstacles to the use of IUDs including pain felt by patients during installation. Several medical means were studied without evidence of their efficacy in pain related to IUD insertion. In order to remove this brake, it's important to find another way to act against this pain. The direct technique is one of the techniques described by health professionals. It seems trusted by its users as a more reliable technique but also less painful for patients. However, there is no study available on its evaluation. The aim of this study is to investigate the interest of the direct technique in reducing the pain experienced by patients during installation.
Interventions
DEVICEIUD
copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any major patient and consultant for IUD insertion : hormonal or copper * Signing of the information and consent form by the patient or, if under supervision by parents or guardian. * Patient affiliated with or entitled to a social security scheme * No contraindication for IUD insertion
Exclusion criteria
* Patient consultant for IUD insertion to side arms * Contraindications for installation. * Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to understand the study and sign the consent * Refusal to sign the consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain measured by Verbal Numeric Scale | intraoperative | Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of vagal discomfort | intraoperative | — |
| Number of expulsion of the IUD | intraoperative | — |
| Number of IUD-fond uterine distance >2 cm | intraoperative | — |
| Number of failure laying direct technique | intraoperative | — |
| Number of emergency department visit for a IUD complication | up to 7 days | — |
| Number of analgesic intake | up to 7 days post-insertion | — |
| Pain measured by Verbal Numeric Scale | day 1 | Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be) |
| Number of expulsion of IUD | up to 7 days | — |
Countries
France
Outcome results
None listed