Clinical trial NCT05956184: Intrauterine Device Insertion and Felt Pain
Official title: Intrauterine Device Insertion and Felt Pain: Which Method is Better?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Device Migration
Keywords: Pain
Intrauterine Devices
Conventional Technique
Direct Technique
IUD
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups as conventional method and direct method
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to compare the pain score between the direct method and the conventional method in patients who have undergone copper or hormonal intrauterine devices (IUD) for contraception and to find an answer to the question of which method is better.

Detailed description: The intrauterine device (IUD) is one of the commonly used methods of contraception due to its effectiveness in providing reliable contraception, its ease of application, non-obstruction of sexual life, affordability, minimal absolute contraindications, and reversibility. Despite this increasing preference, concerns regarding the use of both levonorgestrel-releasing and copper IUDs due to the potential pain and fear of pain during insertion, which has hindered the adoption of this method.

Although the conventional method is used for intrauterine device insertion, the authors defined the direct method, also known as the torpedo technique, in 2006. IUD practitioners have started to prefer this direct method because it is simpler, faster and has fewer insertion steps than the conventional technique. However, IUD practitioners should apply the most painless and tolerable method to women who choose an IUD for contraception. Therefore, in order to understand which method is less painful, patients will be divided into 2 groups as those who have IUD inserted with the conventional method and those who have IUD inserted with the direct method. At the end of the procedure, participants in both groups will be asked to rate the most severe pain they experienced during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).

In the conventional method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD was inserted.

In the direct method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and without using hysterometry the IUD was directly inserted.

Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the study
* Preferring an intrauterine device for the contraceptive method

Exclusion Criteria:

* Patients with uterine leiomyoma
* Patients with endometriosis
* Patients with chronic pelvic pain
* Patients with familial mediterranean fever
* Patients who experienced complications during the procedure
* Patients who developed vasovagal reactions
* Patients who had previously used an IUD for any reason
* Patients with uterine anomalies

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Thirty minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Mohammad I Halilzade, M.D.
role: PRINCIPAL_INVESTIGATOR
References: