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

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Contraception

Treatments

Device: IUD

Study type

Interventional

Funder types

Other

Identifiers

NCT02595125

2015-A01966-43 (Other Identifier)

1508153

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.