Intrauterine Device Insertion and Felt Pain

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.

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Key information

Conditions

Intrauterine Device Migration Foreign Bodies Foreign-Body Migration Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrauterine Device Insertion

Device

All womens will be placed in a gynecological position and underwent a bimanual examination to better determine whether the uterus was in the anteverted or retroverted position. Subsequently, a speculum will be inserted, and the cervix will be disinfected with betadine. In the conventional method: the anterior lip of the cervix is grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD is inserted. In the direct method: the anterior lip of the cervix is grasped and pulled with Pozzi forceps, and without using hysterometry the IUD is directly inserted. The strings will be cut approximately 2-3 cm after the cervix, and the Pozzi forceps and speculum will be removed. The accuracy of the IUD placement will be confirmed using pelvic ultrasound. The process will take about five minutes.

Primary outcomes

Visual Analogue Scale (VAS)

Time frame: Thirty minutes

This is a numeric pain score evaluated as "painless" (score=0) and "worst pain" (score=10). Score <3 mild pain, 3-6 mild-moderate pain, and >6 moderate-to-severe pain.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Intrauterine Device Insertion and Felt Pain: Which Method is Better?

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jul 21, 2023
Registry last updated: Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed