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More than Minimal Risk of PTSD

Written & Recruiting & Consent Information – More than Minimal Risk Study of PTSD with Potential Follow-Up

Post-Traumatic Stress Disorder (PTSD) and Pelvic Pain

Contact Information:

If you think that you might be eligible for this study or for more information, please contact: XXXXXXXX, MD XXX-XXX-XXXX

What are some general things you should know about research studies?

Research studies are designed to gain scientific knowledge that may help other people in the future. You may not receive any direct benefit from participating. There may also be risks associated with participating in research studies.

Your participation is voluntary. You may refuse to participate, or may withdraw your consent to participate in any study at any time, and for any reason, without jeopardizing your future care at this institution or your relationship with your doctor. If you are a patient with an illness, you do not have to participate in research in order to receive treatment.

Details about this particular study are discussed below. It is important that you understand this information so that you can decide in a free and informed manner whether you want to participate. You will be given a copy of this consent form. You are urged to ask the investigators named above, or staff members who may assist them, any questions you have about this study at any time.

What is the purpose of this study?

The purpose of this research study is to:

1. Determine how many patients being seen in a pelvic pain clinic have experienced a trauma and have symptoms of Post-Traumatic Stress Disorder (PTSD).

2. Measure how well patients with pelvic pain are functioning in their everyday activities, and how many pain related symptoms are present.

3. Determine the effects of abuse/trauma and PTSD symptoms on pain, health related dysfunction and medical symptoms among patients with pelvic pain.

How many subjects will participate in this study?

If you decide to participate, you will be one of approximately 300 subjects in this research study.

How long will your participation last?

Your participation in this study will last for approximately thirty minutes. The entire research study will last approximately nine months.

What will happen if you take part in the study?

During the course of this study, the following will occur:

1. We will ask you to complete a survey about medical history, history of traumatic events, ability to function in daily activities, and pain and other related symptoms. The survey will also include questions about any past sexual assaults. We will also want to look at your medical record to review what treatment(s) you have received, or are currently receiving for your pelvic pain symptoms.

2. After completing the survey, you will have the option of providing your name and phone number and giving permission for further contact.

3. If you agree to further contact, you may be invited to participate in a follow-up study of pelvic pain and post-traumatic stress disorder. You would be contacted sometime within the next 9 months for further participation. Further contact would be initiated via a phone call to your home. We will take every step to completely protect your privacy. For example, in the future, if we call you at home and you answer the phone, we will identify ourselves and ask if this is a good time to talk now, or if we should attempt to reach you at a different time. If we call you at home and either an answering machine picks up, or another person answers the phone, we would simply say “We are calling from XXXX Clinics,” and we would leave a name and phone number.

Are there any reasons you should not participate?

You should not participate in this study if you feel that discussing past traumatic events would be harmful to you.

What are the possible risks or discomforts?

This study might involve the following risks and/or discomforts to you:

Your answers to the initial survey may not be reviewed by your gynecologist. Only the research staff reviews the responses to the survey. The questions on the survey include topics related to a history of traumatic events, such as past sexual trauma, and other serious life events. Because this study might involve recalling past traumatic events that may cause some discomfort, it is important that you let someone know if you are feeling uncomfortable. You can tell your doctor or nurse about any discomfort, or ask to speak with a member of the research staff who is available if needed. We can immediately refer you for mental health treatment if you feel that completing the survey has caused you distress. We will take every step to protect your confidentiality. In addition, there may be uncommon or previously unrecognized risks that might occur.

What are the possible benefits?

By participating in this study, you may decide that you would like to pursue therapy for the symptoms related to PTSD or other psychiatric disorders. Please note that there are no right or wrong answers on this survey. However, if answering these survey questions causes anxiety, and/or you feel that speaking with a mental health professional would be helpful, then we encourage you to tell your doctor or nurse that you would like to be referred for treatment. With the information gained from this study, we hope to improve the detection of PTSD symptoms, so that future patients can be identified and treated more quickly.

If you choose not to participate, what other options do you have?

You do not have to participate in this research study in order to receive treatment. You can tell your doctor or nurse about any previous traumatic events and ask for more information about PTSD or the name of a doctor that can help you with cope with any serious life events that you may have experienced.

What if we learn about new risks during the study?

We do not anticipate that there will be any new risks during the study.

How will your privacy be protected?

No subjects will be identified in any report or publication about this study. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, XXXXX will take all steps allowable by law to protect the privacy of personal information.

All subjects will be given study identification numbers and no part of this research will appear in the subjects medical record. All data will be kept in a secured research area in locked file cabinets. Data management is also in a secured research area to further protect privacy.

Will you be paid for participating?

You will not be paid for participating in this research study.

Will it cost you anything to participate?

There will be no costs to you for participating.

Who is sponsoring this study?

This research is funded by the Department of XXXXXXX at XXX.