Chronic Pain, Sickle Cell Disease, Sleep Disturbance
Conditions
Keywords
sleep, mindfulness-based intervention, mobile health, feasibility study, pain management
Brief summary
This study examines the feasibility and acceptability of a mindfulness-based mobile intervention designed to support pain and sleep management among adolescents and young adults with sickle cell disease. Chronic pain and sleep problems are common in this population and can negatively affect daily functioning and quality of life. Participants will use a smartphone-based mindfulness program that includes structured modules and guided mindfulness exercises over an approximately 8-week period. The study aims to evaluate whether the intervention is feasible and acceptable for adolescents and young adults with sickle cell disease.
Interventions
BEHAVIORALMobile bindfulness-based intervention
Participants receive a mindfulness-based mobile intervention designed to support symptom management related to pain and sleep. The intervention is delivered via a smartphone application and includes structured mindfulness content such as guided meditation and brief mindfulness exercises. Participants are asked to engage with the intervention over an approximately 8-week period. The study evaluates feasibility and acceptability.
Sponsors
University of Illinois at Chicago
National Institute of Nursing Research (NINR)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Individuals aged 15-39 years * Have been diagnosed with SCD * Are able to speak and understand English * Are able to complete questionnaires with minimal or no assistance from a caregiver * Report pain and/or sleep problems as assessed by the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) short forms * Have access to the internet on a smartphone, tablet, or computer
Exclusion criteria
* Individuals who have significant cognitive limitations that will impair their ability to use and understand the MBI, as per their health care provider or caregiver * Are currently receiving an MBI or have received more than 4 sessions of any MBI in the 6 months prior to the screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant retention rate | At 8 weeks (post-intervention) | Percentage of enrolled participants who remain in the study through the 8-week intervention period |
| Attrition rate and reasons for withdrawal | Throughout the 8-week intervention period | Percentage of participants who withdraw from the study and documented reasons for withdrawal |
| Weekly module completion rate | At 8 weeks (post-intervention) | Percentage of assigned weekly modules completed by participants |
| Acceptability of the Mindfulness-Based Intervention | At 8 weeks (post-intervention) | Acceptability of the digital mindfulness-based intervention assessed using a study-specific acceptability questionnaire. The questionnaire measures multiple dimensions including comfort level, effort required to engage, perceived fairness for patients with sickle cell disease, perceived effectiveness for pain and sleep management, clarity of intervention purpose, confidence in the intervention, interference with other priorities, and overall acceptability. The questionnaire uses 5-point rating scales for all items. The questionnaire also includes open-ended questions about device use, suggested improvements, and helpful and unhelpful aspects of the intervention. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDahee Wi, PhD, RN
University of Illinois at Chicago
Outcome results
None listed