Research Study Consent Form

 

Study Title:    Chronic pain, Anger, Ambivalence over Emotional Expression and Intrusive Thoughts.

Researchers:  Purnima Jain, Department of Psychology.

                        Prof. Barbara Cherry, Department of Psychology, (657)-278-2731.

                         Dr. Jennifer Trevitt, Department of Psychology, (657)-278-2669.

                        Prof. William Marelich, Department of Psychology, (657)-278-7374.   

 

Informed Consent:

 

You are being asked to take part in a research study carried out by Purnima Jain, Prof. Barbara Cherry, Dr. Jennifer Trevitt and Prof. William Marelich. This consent form explains the research study and your part in it if you decide to join the study.  Please read the form carefully, taking as much time as you need. You can decide not to join the study. If you choose to join the study, you can change your mind later or quit at any time.  There will be no penalty or loss of services if you decide to not take part in the study or quit later. 

 

What is this study about?

 

This research study is being conducted as a partial fulfillment of the requirements for the Master of Science (M.Sc.) degree in Clinical Psychology. You are being asked to take part because we are interested in studying the role of anger, ambivalence over emotional expression, and intrusive thoughts on pain severity among female participants with fibromyalgia. Taking part in the study will take a maximum 90 minutes. You cannot take part in this study if you do not have fibromyalgia, if you cannot understand English, if you are under 18, and if your sex is male.

 

What will I be asked to do if I am in this study?

 

If you take part in the study, you will be asked to complete six questionnaires. These questionnaires are related to your feelings of anger, your ambivalence over expressions of emotions, how your pain feels, and how distressing pain-related thoughts have been. Other questionnaires involve assessing feelings of depression over the past one week, and how pain affects your ability to participate in daily activities.

 

The first questionnaire is the McGill Pain Questionnaire (MPQ). This has 20 categories with words that describe pain experienced during musculoskeletal pain and 4 other questions on how your pain changes over time. This questionnaire will take 10 minutes to complete.

 

The second questionnaire is the Ambivalence over Emotional Expression Questionnaire (AEEQ). This has 28 items that ask about conflict experienced over whether to express your emotions. This questionnaire will take 10 minutes to complete.

 

The third questionnaire is the State-Trait Anger Expression Inventory (STAXI). This has 44-items that ask about how you feel right now, that is, at the moment while other items ask about how you generally feel. This questionnaire will take 10 minutes to complete.

 

The fourth questionnaire is the Impact of Event Scale (IES). This has 8 items that are concerned with how distressing your pain-related thoughts are over the past one week. This questionnaire will take 7 minutes to complete.

 

The fifth questionnaire is the Pain Disability Index (PDI). This has 7 categories in different areas of daily living: home, social, recreational, occupational, sexual, self-care, and life support. These categories are concerned with the impact that pain has on your ability to participate in essential life activities. This questionnaire will take 7 minutes to complete.

 

The sixth questionnaire is the Center of Epidemiological Studies-Depression (CES-D). This has 8 items that are concerned with your feelings of depression over the past one week. This questionnaire will take 7 minutes to complete.

 

There are no right or wrong answers to these questionnaires. Kindly do not spend too much time on any one item in a questionnaire. You are encouraged to answer honestly.

 

Are there any benefits to me if I am in this study?

 

The potential benefit to you for taking part in this study is receiving a $5 Starbucks gift card.

 

Are there any risks to me if I am in this study?

 

This protocol contains no foreseeable risks. You may choose to not answer any question that makes you feel uncomfortable.

 

Will my information be kept anonymous or confidential?

 

Confidentiality will be provided to the extent allowed by law. The data for this study are being collected anonymously.  Neither the researcher(s) nor anyone else will be able to link data to you. No published results will identify you, and your name will not be associated with the findings. The data will be stored at the Fibromyalgia and Chronic Pain Center, CSUF. Only professors, researchers, and students working on their theses/dissertation at the Fibromyalgia and Chronic Pain Center, CSUF, will have access to the data collected in this study. The data will be used for research purposes only. The results of this study may be published or presented at professional meetings, but the identities of all research participants will remain anonymous. The data will be kept indefinitely.

 

Are there any costs or payments for being in this study?

 

There are no costs to you to participate in this study. Additionally, you will not receive money or any other form of compensation for taking part in this study.

 

Who can I talk to if I have questions?

 

If you have questions about this study or the information in this form, please contact the researcher Purnima Jain at pjain@csu.fullerton.edu or Dr. Barbara Cherry at bcherry@exchange.fullerton.edu or (657)-278-2731. If you have questions about your rights as a research participant or would like to report a concern or complaint about this study, please contact the Institutional Review Board at (657) 278-7640 or e-mail irb@fullerton.edu

 

What are my rights as a research study volunteer?

 

Your participation in this research study is completely voluntary.  You may choose not to be a part of this study.  There will be no penalty to you if you choose not to take part.  You may choose not to answer specific questions or to stop participating at any time. 

 

What does my signature on this consent form mean?

 

Your signature on this form means that:

·   You understand the information given to you in this form.

·   You have been able to ask the researcher questions and state any concerns that you may have.

·   The researcher has responded to your questions and concerns.

·   You believe you understand the research study and the potential benefits and risks that are involved.