Document Type : Original Research Article
Authors
1
a) PhD of Reproductive Health, Research Center for Nursing and Midwifery Care, Non-Communicable Disease Research Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran b) Department of Midwifery, School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
2
Assistant Professor, Department of Professional Ethics, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Abstract
Background & aim: Despite its efficacy, the intrauterine device (IUD), a widely used reversible contraceptive, carries inherent risks, necessitating careful consideration and informed consent. However, there is a notable gap in specific studies addressing the design of an informed consent form for IUD placement. This study aims to fill this void by utilizing the Delphi method to create a comprehensive informed consent form tailored for IUD insertion.
Methods: A descriptive research approach was employed at Yazd University of Medical Sciences (2019-2018) using the Delphi technique. A panel of 30 experts, including gynecologists, midwives, and reproductive health specialists, participated in three Delphi rounds. A draft of the IUD insertion informed consent form was prepared based on literature studies, previous research, and expert opinions. The Delphi rounds aimed to establish necessity, determine item importance, and gauge expert agreement.
Results: Three Delphi rounds were conducted with 28, 24, and 24 participants, respectively. The consent form, designed in nine general areas, underwent review and refinement. Items with 75% agreement or more were accepted in the first round, while those with 25% agreement or less were removed. The second and third rounds considered agreement levels above 75% and change rates below 15%. An acceptable consensus above 51% was reached, resulting in a finalized informed consent form with five sections: demographic characteristics, general IUD placement features, contraindications, patient responsibilities, and declaration of consent.
Conclusion: Implementing the informed consent form in the clinical process of IUD placement is essential for respecting the client's autonomy in selecting a pregnancy prevention method, minimizing risks, addressing clinical consequences, and fulfilling legal responsibilities.
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