Invitation to participate in a research study.
Title: An investigation into mental, physical, and sexual health in those with endometriosis
Letter of Information
Investigators:
Samantha L. Levang, BAH, Department of Psychology, Queen's University
Caroline F. Pukall, PhD, Department of Psychology, Queen's University
Shannon M. Coyle, MA, Department of Psychology, Queen's University
Introduction and Purpose of the Study:
You are being invited to participate in an online research study led by researchers at Queen’s University in Kingston, Ontario, Canada. This study seeks to find out how people who have endometriosis are faring in terms of their physical and mental health, sexual well-being, and quality of life over a 12-month period.
Participation is voluntary and you can decline to participate in the research or any aspect of the research at any time without penalty/loss of benefits.
Eligibility:
In order to participate, you must be 18 years of age or older, be able to read and write fluently in English, be in an intimate and/or romantic relationship, and have a diagnosis of endometriosis. You must also be comfortable answering questions about sexuality, your health (physical and mental), and pain.
Study Procedures:
Your participation in this study is voluntary and you are free to withdraw at any time without any penalty. Should you choose to participate, you will be asked to complete 3 surveys at the following time points outlined below. Should you choose to participate in future time points, you will be asked to consent and confirm at the end of each survey by providing your email address. Your email address will be used to link data over the 3 time points, and downloaded data will be de-identified immediately once linked (meaning your name and personal information will not be attached to your responses; responses will just be identified by a participant number).
The survey contains questionnaires asking about sociodemographic information (e.g., age, education), pain characteristics (e.g., location, intensity), medical history, emotional and cognitive function, sexual function, and relationship satisfaction. Members of the research team will be available by email (sex.lab@queensu.ca) to answer any questions that you may have about the survey and/or the study.
Study time points:
• Time 1 survey (approximately 45-60 minutes)
• Time 2 survey (approximately 45-60 minutes) 6 Months after Time 1
• Time 3 survey (approximately 45-60 minutes) 6 Months after Time 2
Your responses will remain confidential. You can go back to previously completed pages by pressing the Back button (if it appears).
Research findings from this study may be presented at relevant conference organizations (e.g., Canadian Sex Research Forum, Society for Sex Therapy and Research), published in peer-reviewed journals (e.g., Journal of Sexual Medicine, Journal of Sex Research), and/or posted to the Sexual Health Research Laboratory website as a blog (https://www.sexlab.ca/blog) and/or infographic.
Compensation:
To thank you for your time and participation in the study, you will have the opportunity to choose to be entered into a draw to win an Amazon or other e-gift card in Canadian dollars (or equivalent) for each survey time point should you choose to participate.
• Time 1 Survey: Chance to win one of 50 prize draws of $20 e-gift cards.
• Time 2 Survey: Direct compensation of a $10 e-gift card, PLUS a chance to win one of 10 prize draws of $25 e-gift cards.
• Time 3 Survey: Direction compensation of a $20 e-gift card, PLUS a chance to win one of 10 prize draws of $50 e-gift cards.
On completion of the survey at each timepoint, if you wish to enter your email address into the prize draw/confirm email for payment [Time 2, 3], you will be directed to a separate survey to enter this information. If you have chosen not to continue with participation, you can still enter your email address after the debriefing, and it will be stored in a separate survey from your responses until prize draw winners have been selected. Survey responses and prize draw email entries are kept in 2 separate databases to keep your responses separate from your email address.
Advantages of Participating in this Study:
There are no direct benefits of participating in this study. The information in this study may provide us with a more comprehensive understanding of the psychological variables associated with adaptive outcomes in the endometriosis population.
Risks of Participating in this Study:
There are no known physical, economic, or social risks associated with participating in this study. However, some of the questions cover sensitive topics, such as current physical and emotional condition, as well as sexual functioning. Due to the intimate nature of the survey items, you may come across questions or parts of the study that you find too personal, unpleasant to think about, or perhaps objectionable. You may experience psychological or emotional discomfort or distress responding to these questions. However, you are not in any way obligated to answer any material that you find objectionable or that makes you feel uncomfortable; there will be a ‘decline response’ option for each question. You may also withdraw from the study at any time by closing your browser window. Sexuality and mental health resources are also provided in the debriefing form.
Discontinuation of this Study:
You are under no obligation to participate in this study. Furthermore, you may choose to discontinue the study at any time without penalty and you may refuse to answer any of the questions that you are asked without providing an explanation for your refusal to answer. All of the online questions have a ‘decline response’ option that you may choose should you decide that you do not want to provide an answer. Should you wish to withdraw from the study, you can do so at any time by either closing the browser window or selecting ‘decline response’ for the remaining questions. If you discontinue your participation by closing your browser window, you will not have access to the study’s Debriefing Form, nor will you have the option to enter into our prize draw; however, you may still contact the researchers if you wish to have access to the study’s Debriefing Form.
If you wish to withdraw your data from the study, you may only do so if you elected to provide your email address to participate in future time points. Without providing an email, the data is not identifiable. You have 13 months to withdraw data, which is the duration from time 1 to a month after time 3 of participation.
If you would like further information about the study, or have additional questions or concerns, you may contact the study research associate Shannon Coyle directly at sex.lab@queensu.ca or the lead investigators: Dr. Caroline Pukall, at caroline.pukall@queensu.ca, or Samantha Levang, at sex.lab@queensu.ca
If you have any ethics concerns, please contact the General Research Ethics Board (GREB) at 1-844-535-2988 (Toll free in North America) or email chair.GREB@queensu.ca.
Liability:
By clicking “yes, I agree to participate” on this consent form, you do not waive your legal rights nor release any investigator(s) and sponsors from their legal and professional responsibilities.
Confidential Nature of this Study:
All questionnaire information obtained during the course of this study is strictly confidential and your privacy will be protected at all times.
For participants who agree to participating in Times 2, and 3, we will be asking for your consent to link your surveys at the different timepoints via your email address. If you consent to this linking of data, you will provide your email address at the end of the current survey and your data will be saved in a password-protected database on our secure and password-protected servers. Your email address will be used to link your responses for each timepoint you consent to participant in. Only the people directly involved in the study and named on this form will have access to this document. Once all of your data have been linked, your email address will be securely removed and deleted from the document. No other identifying information will be collected or linked to your questionnaire responses.
If you provide your email address to be contacted for future studies, this will not be linked to the data you provide in the current survey. Your email address (should you choose to provide it for compensation and/or future research) will be saved in a separate, secure database from your survey responses.
Questionnaires will be administered through Queen's University's new Enterprise Software System, Qualtrics. Data collected by Qualtrics at Queen's University will be stored in their data center in Toronto, Canada and backup data in our Amazon Web Service (AWS) which is located in Montreal, Canada. Participants will receive email reminders and may complete the questionnaires in a location and on a device of their choosing.
Your responses to the questionnaires (without any identifying information) will be downloaded from Qualtrics and stored on encrypted and password-protected hard drives (Synology) stored in the Sexual Health Research Laboratory at Queen’s University Campus. You will not be identified in any publication or reports of the study; data will be combined in all reports of this study. The de-identified electronic data will be maintained indefinitely to allow the investigators to answer future research questions with archived data. Electronic data files will not contain any identifying information (e.g., name, contact info, etc.).
Data collected from the study will be analyzed in aggregate form (in other words, all together), and will be communicated via publication in journal articles, presentations, and through the Queen’s Health Research Lab’s website (www.sexlab.ca). No personally identifying details will be included in the dissemination of the results.
The Queen’s General Research Ethics Board (GREB) may request access to study data to ensure that the researcher(s) have or are meeting their ethical obligations in conducting this research. GREB is bound by confidentiality and will not disclose any personal information.
Your participation in this study is completely voluntary. You may withdraw from this study at any time without any consequence by simply exiting the survey. You have not waived any legal rights by consenting to participate in this study. You may retain a copy of this Letter of Information, for your own records, by clicking [here].