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"Mental Health after removing the hormonal IUD"

Information for participants in the study "Mental health after removing the hormonal IUD"


Dear participant,

Thank you for your interest in this scientific study. Before you can participate, we require your written consent. We kindly ask you to take a moment to read the following information about the study.

This survey is anonymous.

The record of your survey responses does not contain any identifying information about you, unless a specific survey question explicitly asked for it.

If you used an identifying access code to access this survey, please rest assured that this code will not be stored together with your responses. It is managed in a separate database and will only be updated to indicate whether you did (or did not) complete this survey. There is no way of matching identification access codes with survey responses.

Privacy policy

General information about the study

The aim of this study is to gain a deeper insight into the mental health of women after discontinuing the use of hormonal or copper IUDs. For this purpose, women who have had their hormonal or copper IUD removed within the last 6 months or who do not use hormonal or copper-based contraceptives are surveyed. The study covers a period of up to 6 months after the removal of the respective IUD. In the case of no hormonal or copper-based contraceptives being used, any period of 6 months will be examined.

 

Procedure

Participation is exclusively online and involves a single survey. This will take approximately 20-30 minutes and collect the following data:
-    Information on demographics,
-    trait anxiety,
-    cycle phase,
-    mood questionnaires,
-    questions about possible premenstrual syndrome (PMS) symptoms 

 

 

Exclusion criteria

 

Unfortunately, we cannot include you in the study if you are pregnant, male, younger than 18 years of age, still use the hormonal or copper-based IUD or use another type of contraception (e.g., the pill). We also cannot include you in the study if you currently suffer from a serious mental, neurological, endocrinological, or cardiovascular disease, such as psychosis or substance dependence, multiple sclerosis, epilepsy, or hyperthyroidism or hypothyroidism. Furthermore, you cannot participate in the study if you are currently taking medication that can affect your mood (occasional use of painkillers is not a problem).

 

Rights

 

Your participation in the study is voluntary and you can withdraw from the study at any time, even without giving reasons, and/or request that your data be deleted without incurring any disadvantages whatsoever (see below for details). Obligations As a participant, you are obliged to provide information about the above exclusion criteria. To ensure that the study runs smoothly, we depend on your cooperation. This means that it is very important that you follow the planned procedure, read the instructions carefully, and answer truthfully and to the best of your knowledge and belief. Benefits Your participation is unlikely to be of any personal benefit to you. However, the scientific findings from this study will contribute to a better understanding of mental health and well-being after IUD removal. If you wish to learn about your own study results, you can give your email adress at the end of the survey.

 

Risks and inconveniences

 

The procedures described are not harmful to health and comply with international scientific standards. However, the above-mentioned process and measurement methods involve the following minor risks and possible inconveniences: Since questionnaires on mood, depression, or anxiety are used, dealing with one's own feelings may occasionally be experienced as emotionally demanding.
Should unforeseen or undesirable events in the form of emotional distress occur, we will take the following measures: At the end of the questionnaire, you will find information on psychosocial support services that are available to you.
You can withdraw from the study at any time without any disadvantages by closing your internet browser. Your data will then be deleted immediately.

 

Confidentiality and processing of personal data

 

All data we record from you is anonymized at the time of data collection or immediately thereafter. This means that this data can no longer be attributed to a specific person, or only with disproportionate effort. Your data will only be evaluated in this anonymized form and communicated to other scientists or to the public. If the consent form you have signed contains your name, it will be kept separate from the study data collected for a period of 30 years by the study management in a locked cabinet or on a password-protected computer at Paris Lodron University of Salzburg and will no longer be associated with your study data. 

For this study, it is necessary to process your personal data listed below: Name, contact details (telephone number, email address), date of birth, demographic data (age, country of residence), physical characteristics (gender, medical conditions, time of cycle, information on the use of the hormonal IUD), psychological characteristics (self-assessment, mood, depression, anxiety, premenstrual symptoms).
Your date of birth and physical characteristics are collected for the purpose of checking the exclusion criteria that apply to this study. Demographic and psychological data are collected for the purpose of answering the research question of this study.

Your declaration of consent will be stored securely for a period of 30 years. Your pseudonymized study data may be stored for up to 30 years after completion of the research project at Paris–Lodron–University Salzburg. Your data will be stored exclusively at Paris–Lodron–University Salzburg locations. Data security is guaranteed at an appropriate level. You have the right to access, correct, delete, and restrict your pseudonymized study data stored by us. You can also revoke your consent at any time. Revocation means that we will no longer process your data for the above-mentioned purposes from that point on. To revoke your consent, please contact the study management listed below.
Your data may also be used in anonymized form (i.e., this data can no longer be attributed to you or can only be attributed to you with disproportionate effort) for other scientific purposes (e.g., open science databases, new types of evaluation and publication) without your consent, insofar as this is ethically and legally permissible. If you believe that we are violating data protection regulations, you can complain to the data protection officer at Paris–Lodron–University Salzburg (datenschutz@plus.ac.at) or to the Austrian Data Protection Authority (dsb@dsb.gv.at). Further information can be found at https://www.plus.ac.at/datenschutz.

 

Reimbursement 

 

You will not receive any financial compensation for your participation. If you are a psychology student at the University of Salzburg, you can have your participation credited to your studies in the form of test subject hours. You will receive 1.5 test subject hours for your participation.

 

Contact persons

 

If you have any questions during or after the study, please contact the following persons:
• Study director: DDr. Belinda Pletzer, Department of Psychology, University of Salzburg, Hellbrunnerstraße 34, A-5020 Salzburg, Tel.: +43-662-8044 5184, Belinda. Pletzer@sbg.ac.at
• This study has been evaluated by the Ethics Committee of the University of Salzburg. Contact: Ethics Committee Office, Mag.a Clara Gröblacher, Kapitelgasse 4-6, A-5020 Salzburg, Tel: +43-662-8044 2391, clara.groeblacher@plus.ac.at

 

Declaration of consent

I have read and fully understood the information about the study. Any additional questions I had have been answered to my satisfaction by the principal investigator. My participation is voluntary, and I understand that I can withdraw from the study at any time, without giving reasons, and without suffering any disadvantages whatsoever as a result.