Study Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Study, Prospective, Randomized , Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique. A Monocentric Study

Conditions
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Contraception

Intervention / Treatment
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* Device: IUD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Conventional technique<br>Intrauterine device (IUD) insertion by the conventional technique | Device: IUD<br>* copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique<br>|
| Experimental: Direct technique<br>Intrauterine device (IUD) insertion by the direct technique | Device: IUD<br>* copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured by Verbal Numeric Scale | Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be) | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of failure laying direct technique |  | intraoperative | 
| Number of vagal discomfort |  | intraoperative | 
| Number of expulsion of the IUD |  | intraoperative | 
| Number of IUD-fond uterine distance >2 cm |  | intraoperative | 
| Number of expulsion of IUD |  | up to 7 days | 
| 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 | Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be) | day 1 | 
| Pain measured by Verbal Numeric Scale | Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be) | day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrauterine device, contraceptive method, direct technique, torpedo technique, verbal numeric scale