Intrauterine Device Insertion and Felt Pain

NCT05956184 | Completed

• 1 other identifier: ACH-KHD-MIH-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Device Migration

Keywords

Pain; Intrauterine Devices; Conventional Technique; Direct Technique; IUD

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  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.

  Thirty minutes

Study Arms (2)

Convention Method Group

ACTIVE COMPARATOR

Women who have an IUD inserted by conventional method will be asked to rate the most severe pain they experience during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).

Device: Intrauterine Device Insertion

Direct Method Group

ACTIVE COMPARATOR

Women who have an IUD inserted by direct method will be asked to rate the most severe pain they experience during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).

Device: Intrauterine Device Insertion

Interventions

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.

Convention Method Group; Direct Method Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women using an intrauterine device as a birth control method
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (1)

• Halilzade MI, Halilzade I, Turgay B, Kilickiran H, Turkmen O, Ozaksit MG. Effect of uterine sound on pain perception during intrauterine device insertion: A randomized trial. Medicine (Baltimore). 2025 Aug 1;104(31):e43721. doi: 10.1097/MD.0000000000043721.

  PMID: 40760565 DERIVED

MeSH Terms

Conditions

Intrauterine Device Migration; Pain

Condition Hierarchy (Ancestors)

Foreign-Body Migration; Foreign Bodies; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad I Halilzade, M.D.

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not know which method would be applied to them.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Two groups as conventional method and direct method

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: July 13, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)