Seattle Children's Hospital
Seattle, Washington, 98101, United States
Location status: Recruiting
NCT Number: NCT06932432
The goal of this observational study is to determine real-time contextual vulnerabilities associated with pain in young adults to inform ideal treatment targets for a just-in-time adaptive intervention (JITAI). The main question it aims to answer is:
-What contextual factors and vulnerabilities will predict momentary, next-day, and weekly pain severity? 50 young adults, ages 18-25 with a diagnosis of childhood-onset primary chronic pain, will complete 1) baseline questionnaires on REDCap to collect data on sociodemographics, medical history and treatment, psychological health (i.e., current mood symptoms and previous psychiatric conditions/treatment), and pain (e.g., duration, location) and 2) a 28-day EMA via mobile app to collect survey data on dynamic factors.
Interested in participating?
Request Info18 year–25 year
All sexes
Observational
Seattle, Washington, 98101, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Three times a day for 28 days
One item from the Brief Pain Inventory will assess momentary pain intensity (yes/no), followed by "How much pain do you feel on average?" (11-point NRS)
Time frame: Three times a day for 28 days
Two items from the Brief Pain Inventory will assess pain interference with enjoyment in life, and general activity. Higher scores indicate more interference.
Time frame: Once a day for 28 days (morning)
1-item from from the Insomnia Severity Index, "How would you rate the quality of your sleep last night?" will be rated on an 11-point NRS. 10 is equivalent to extremely good sleep and 0 indicates extremely poor sleep.
Time frame: Three times per day for 28 days
2-items to collect, "Was anyone with you right before you received this survey?" and "Who were you with right before you received this survey?"
Time frame: Three times a day for 28 days
One-item question to collect "Where were you right before receiving this survey?" in addition to GPA data with minute-to-minute mobility patterns collected via the Pathverse app
Time frame: Three times a day for 28 days
Two-items to assess fear associated with pain. Ratings of 0 indicate not at all and ratings of 4 indicate all the time
Time frame: Three times a day for 28 days
Ten items from the Positive and Negative Affect Schedule will measure the extent to which a positive or negative feeling is experienced on a 5-point likert scale. 1 represents 'very slightly or not at all' and 5 indicates 'extremely'.
Time frame: Three times a day for 28 days
Three items from the Pain Catastrophizing Scale will assess the extent of catastrophic thinking due to pain. Higher scores are associated with higher amounts of pain catastrophizing.
Time frame: Three times a day for 28 days
Three items from the Brief Pain Inventory will measure pain intensity and pain interference on an 11-point numeric rating scale. 10 indicates 'pain as bad as you can imagine' and 'completely interferes'.
Time frame: Once a day for 28 days (evening)
Two items, to assess how kind oneself has been to others and oneself in the past 24 hours. A rating of 0 indicates, 'not at all', and a rating of 10 means 'very much so'.
Time frame: Once a day for 28 days (evening)
One item to assess "Over the past 24 hours, how much has your pain brought back memories of times when you felt your pain had taken over your life?" Response options use a 0 through 10 numeric rating scale, 0 indicates 'not at all' and 10 indicates 'Very much so'.
Time frame: Once a day for 28 days (evening)
One item to gather what substances were used within the last 24 hours. Response options include: Alcohol, Tobacco, Marijuana, Other (please specify), None of the above.
Time frame: Once a day for 28 days (evening)
One item to assess pain coping strategies used in the last 24 hours. Response options include: Distracted myself (e.g., hobbies, fun activities, talk with friends), Tried to relax, Looked for support from someone (talk on the phone, spend time), Didn't let my pain get me down, Still worked to accomplish my goals, Used cold or heat compresses, Drank alcohol, Used a drug, Just accepted my pain, Other (please specify), Nothing
Time frame: Once a day for 28 days (evening)
Three items to assess treatments or medications received for pain in the past 24 hours
Time frame: Once a day for 28 days (evening)
Three items to measure activity patterns over the past 24 hours. Response options use a likert scale, 0 meaning 'not at all' and 4 indicating 'all the time'.
Contact information is provided by the study sponsor or research team.
Seattle Children's Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06518720
Chronic Pain, Depressive Disorder
Toronto, Ontario, Canada
View Trial DetailsNCT06183281
Chronic Pain, Neurologic Manifestations
San Francisco, California, United States
View Trial DetailsNCT05561595
Body Weight, Cancer
Gainesville, Florida, United States
View Trial DetailsNCT07711795
Behavior, Chemically-Induced Disorders
Albuquerque, New Mexico, United States
View Trial Details