Integrative Training Program for Pediatric Sickle Cell Pain
Recruiting · NCT06691867 · Interventional (participants receive a specific treatment) · Lead sponsor: Emory University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This research aims to answer the question: does a group training program specifically for teens with chronic sickle cell disease (SCD) pain that teaches skills to strengthen the mind and body help improve everyday functioning and reduce pain symptoms? The program will be tailored to address challenges related to frequent or chronic sickle cell pain and may improve participants' physical and emotional health. The program, called I-STRONG for SCD (Integrative Strong Body and Mind Training for Sickle Cell Disease), may help improve everyday functioning and pain symptoms in teens with chronic pain related to SCD. The research team aims to determine how participants (teens and parents) respond to this program.
Who can take part
Inclusion criteria
- Provision of signed and dated informed consent form for adolescents 18 years old and caregivers' participation
- For children \<18, informed assent and parental informed consent to participate in the study
- Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Males and females; Ages 12-18 years for adolescents; no age limitations for caregivers
- Documented diagnosis of sickle cell disease (any genotype) for adolescents
- Adolescent scores at least 3 on the Pediatric Pain Screening Tool
- Adolescent reports typical pain intensity in the past week at least 4 on a 0-10 cm Visual Analog Scale
- Adolescent on stable disease-modifying treatments, if applicable (e.g., hydroxyurea, glutamine, voxelotor, crizanlizumab) as defined by not newly initiated or significantly increased dosages (mg/kg) in the past 3 months
- Speak and read English
Exclusion criteria
- An adolescent has comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
- Adolescent has undergone genetic or hematopoietic stem cell therapy
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation
- Adolescents receiving active treatment (e.g., weekly appointments with a provider) for nonpharmacological therapies (e.g., structured behavioral pain management, physical therapy, or acupuncture program) that overlap with the active phase of the study intervention
Where it is running
4 locations listed across 3 US states.
- Connecticut Children's Medical Center - Hartford, Connecticut, United States
- Children's Healthcare of Atlanta - Atlanta, Georgia, United States
- Arthur M. Blank Hospital | Children's Healthcare of Atlanta - Atlanta, Georgia, United States
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States