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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-24

Study Completion Date

2017-07-19

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.

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Conventional technique

Intrauterine device (IUD) insertion by the conventional technique

Group Type SHAM_COMPARATOR

IUD

Intervention Type DEVICE

copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique

Direct technique

Intrauterine device (IUD) insertion by the direct technique

Group Type EXPERIMENTAL

IUD

Intervention Type DEVICE

copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique

Interventions

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IUD

copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No