Clinical trial NCT02595125: Study Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique
Official title: Comparative Study, Prospective, Randomized , Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique. A Monocentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: intrauterine device
contraceptive method
direct technique
torpedo technique
verbal numeric scale
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain measured by Verbal Numeric Scale
timeFrame: intraoperative
Secondary outcomes:
measure: Number of failure laying direct technique
timeFrame: intraoperative
measure: Number of vagal discomfort
timeFrame: intraoperative
measure: Number of expulsion of the IUD
timeFrame: intraoperative
measure: Number of IUD-fond uterine distance >2 cm
timeFrame: intraoperative
measure: Number of expulsion of IUD
timeFrame: up to 7 days
measure: Number of emergency department visit for a IUD complication
timeFrame: up to 7 days
measure: Number of analgesic intake
timeFrame: up to 7 days post-insertion
measure: Pain measured by Verbal Numeric Scale
timeFrame: day 1
measure: Pain measured by Verbal Numeric Scale
timeFrame: day 7
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Céline Chauleur, PhD
role: PRINCIPAL_INVESTIGATOR
References: