Q: What is the purpose of the study?

A: The purpose of this study is to reach a better understanding of the experience children have when they are in pain. What you and your child tell us will form part of a collection of interviews which will help us to understand the real experience of children in pain, both in the past and in the present, and how this experience changes as a result of treatment. This understanding may help to improve the treatment of other children with chronic pain.

Specifically…

• We want to understand your child’s own personal experience of being in pain.
  
  
• We want to learn how you understand what your child is going through.
  
  
• We want to understand how your family’s perceptions and understanding of pain differ from those of the doctors, and if and how these perceptions change during the course of treatment at the clinic.
  
  
• We want to understand your child’s experience of the treatments he or she will receive in the Clinic.
  
  
• We want to hear your observations about the clinic treatments and your experiences there.

Q: Who is conducting the study?

A: The UCLA Interdisciplinary Group for the Study and Treatment of Pain is funded by the National Institute of Health. The principal investigators are Margaret Jacob, PhD, of the UCLA Department of History, and Lonnie Zeltzer, MD, from the UCLA Department of Pediatrics. Additional members of the team include Marcia Meldrum, PhD, from the Department of History, John Heritage from the Department of Sociology, Heather Krell, MD, and Jennie Tsao, PhD, from the UCLA Pediatric Pain Program, and affiliated clinicians from UCLA and Cedars-Sinai Medical Center. For a complete list of the Pain Study team and their backgrounds, click here

Q: Who is eligible to participate in the study?

A: Children ages 10-17, living in Southern California, with any kind of recurrent pain are eligible to participate, with the permission of the child and informed consent of a parent or guardian. If a child is eligible, then a parent or guardian will also be asked to participate in the study.

Q: If you and your child agree to join the study, what will you be asked to do?

A: There are four parts to the study:

1. Parent and Child Questionnaires: First, you and your child will be asked to complete questionnaires about your child’s pain problem and his or her overall health and daily life.
   
   
2. We will interview you and your child before your child’s first clinic appointment. If both you and your child agree to participate, we will schedule an interview to take place in your home at your convenience. A specially-trained member of the research team will ask your child some questions about his or her overall health and daily life. This interview should take less than two hours and will be videotaped. Your child does not have to answer any questions that he or she does not wish to answer.
   At the same time that your child is being interviewed, another trained researcher will ask you some questions about your understanding of the child’s pain and how it has affected the family. This interview will also be videotaped. You will not have to answer any questions that you do not wish to answer.
   
   
3. With your permission, we will videotape your child’s initial clinical appointment. This will allow us to observe how the doctors interact with you and your child. We are interested in how your doctors ask questions and explain their thinking to you and how you and your child share your experiences and observations with them.
   Immediately following this appointment, we will briefly discuss your impressions of the appointment. This discussion will take approximately five minutes and will also be videotaped.
   
   
4. Six months after the clinic appointment,we will ask you and your child to complete a second set of questionnaires similar to the first and participate in a second home interview. At your convenience, we will schedule a time to meet you and your child at home for a final interview. During this interview, we will ask your child to tell us more about what he or she has experienced since the first interview and to talk about his or her experiences at the clinic and with the therapists he or she has seen. We will also talk to you about your impressions of the clinic and your child’s treatment there. Both parts of the interview should last less than two hours and will be videotaped. The study will end with this interview. That’s it.

Q: How long will the study take?

A: Your participation in the study will last approximately six months, from the first home interview to the final follow-up interview.

Q: Where do the interviews take place?

A: The oral history interviews will be conducted in your home at your convenience.

Q: How long does each interview last?

A: The home interviews generally run about 60-90 minutes each for parent and child. We can arrange for these interviews to be done simultaneously or at different times, at the family’s convenience.

Q: Will the study affect my medical care?

A: Participation is voluntary. If you or your child choose not to participate, that will not in any way affect your child’s relationship with the Medical Center or your child’s right to health care or other services to which your child is otherwise entitled. If you or your child decide not to participate, you are free to withdraw consent and discontinue participation at any time without prejudice to future medical care.

Q: What are the potential risks to us if we participate?

A: There are no risks greater than you or your child would have if you were talking to a friend or teacher. On our part, we will conduct the interview in as sensitive a manner as possible.

Q: What are the potential benefits of our participation?

A: These interviews are designed to help us understand your child’s experiences of pain. Although your child may feel better after sharing his or her experiences in an open manner, the interviews are not designed to relieve your child’s pain.

The major benefit is that you and your child will be helping other children who have recurrent pain. What you tell us will help researchers better understand what it really means to be in pain. This understanding may help doctors give patients more effective and more compassionate treatment. It may also help in planning health care programs that take into account the needs of children like your child.

Q: Does it cost anything?

A: There are no charges to the patient or the patient’s family associated with the study, and the study should not impact other medical costs the family might assume during medical consultation or treatment.

Q: What if I change my mind?

A: If, after agreeing to participate in the study, you or your child later decide not to participate, you or your child are free to withdraw consent and discontinue participation at any time without prejudice to his or her medical care.

Q: What about my privacy?

A: The only people who will know that your child is a research participant are you and the members of the research team. No information about you or your child will be disclosed to others without your permission, with two exceptions: if necessary to protect your child’s rights or welfare (for example, if your child needs emergency care); or if required by law.

Your name and your child’s name and other personal particulars will be known only to the research team and to the Clinic staff who treats the child. The tapes and other interview material will have only a code number on them as identification, and any information linking the code number to you or your child’s identifying information will be filed separately from the interviews, with access restricted to the research team.

Q: Why do you videotape the interviews?

A: The videotaping is necessary so that those who will study the experience of pain in the future will hear about your experiences directly from you and your child. They will be able to observe directly what the doctors say to you - and how you respond - to arrive at an understanding of your child’s pain problem.

Q: What happens to the videotapes and transcripts after the study ends?

A: The tapes and transcripts can be disposed of in one of three ways. You and your child will be asked to choose the option that best suits you both:

1. The tapes may be stored in a special area at the UCLA Biomedical Library. You and your child may choose to allow qualified researchers to begin studying them immediately under the supervision of library staff.
   
   
2. You and your child also have the right to deposit the materials at the library but to block the viewing or hearing of your own interviews for any period up to 100 years. For example, if your child requests in 2006 that his or her tapes be blocked for 20 years, the library will allow researchers to see and hear them beginning in the year 2026.
   
   
3. If you or your child do not wish the tapes to be preserved at all, we will respect those wishes and destroy the tapes and transcripts.

At the end of the study, you will be given a form to fill out and return, instructing us as to which of these three options you have chosen. We will respect that choice.

If a family enrolls in the study and subsequently withdraws before completing all procedures, all tapes and transcripts will be destroyed.

Q: Who do I turn to with medical questions regarding my child?

A: All medical questions regarding symptoms or treatment of your child should be addressed directly to your physician. Pain Study personnel are not permitted to consult with you on medical issues.

Q: What if I move to a new address or change phone numbers during the study?

A: Please let us know of any change in your contact information during the six-months that you are participating in the study. You can update your address, phone number, or email address by contacting Marcia Meldrum at (310) 794-6290 or by email at mlynnmel@earthlink.net.

Q: What if I have other questions about the study?

A: Please contact Marcia Meldrum, PhD with any questions you have about the study. You can reach Dr. Meldrum by phone at (310) 794-6290 or by email at mlynnmel@earthlink.net.