What will happen in the study?
This study includes two study visits. The first visit will last about 1 hour, and the second visit will last about 1.5 hours. Here are some of the things that will happen in this study:
Participants will:
- Be asked to complete a health form and other forms to determine if they are eligible for the study.
- Complete questionnaires to help us understand their personality, how they cope with problems, how they feel about themselves, mood, sleep and emotional well-being, etc.
- Wear an activity measurement device which looks like a watch on their wrist for one week. This device measures the amount and intensity of movement and light, as well as information about sleep, which could be related to pain.
- Be asked to complete a daily dairy (either a paper copy or online version) each day for up to a week. The diary includes questions about sleep and symptoms he/she feels during the day. It needs to be completed in the morning after waking up and in the evening before going to bed.
- Submit blood and saliva samples.
- Undergo a series of short assessments to determine how their body feels pain including (he/she can say stop at any time they feel too much pain or discomfort):
- Pressure sensations - with a handheld device that applies pressure to his/her forearm, the back of the neck and/or the lower leg
- Cold sensations to see sensitivity to cold – by placing his/her hand into a temperature-controlled water bath
- Pinprick sensations – with a handheld probe that will apply pulses to his/her face and hand
Parents and participants will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.