[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07648043":3,"trial-entities:NCT07648043":85,"trial-summary:NCT07648043":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":58,"locations":61,"central_contacts":80,"overall_officials":82,"references":83,"see_also_links":84},"NCT07648043","26-307","Feasibilty and Acceptability of Amani","Feasibilty and Acceptability of Amani, a Virtual Reality Application for Adults With Sickle Cell Disease","NOT_YET_RECRUITING","2028-04-30","2026-05","2026-06-15","2027-01-01","Massachusetts General Hospital","OTHER",false,"Adults with sickle cell disease (SCD) experience severe pain, emotional distress, and social isolation that diminish their quality of life. This project will test Amani, a novel virtual reality supportive care intervention designed to improve coping skills and strengthen peer support. If feasible and acceptable, Amani offers an accessible digital supportive care intervention to improve psychological well-being and quality of life among individuals living with SCD and potentially other chronic illnesses.",null,[19],"Sickle Cell Disease",[21,22,23,24,25],"sickle cell disease","virtual reality","non-pharmacologic analgesia","social support","coping","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"EARLY_PHASE1",{"count":31,"type":32},40,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Amani","Amani is a multi-component VR supportive care intervention specifically tailored for adults with SCD. Amani integrates mindfulness-based pain management exercises, psychoeducational modules to build adaptive coping strategies, and facilitated VR group sessions to reduce isolation and foster peer support.",[36],[40],{"measure":41,"description":42,"timeFrame":43},"Feasibility","Amani will be feasible if ≥50% of eligible patients enroll and if ≥60% of enrolled participants complete the educational modules and attend ≥60% of Amani group sessions.","From enrollment to end of treatment (6 weeks)",[45],{"measure":46,"description":47,"timeFrame":43},"Acceptability","Amani will be acceptable if ≥80% enrolled patients report a System Usability Score ≥ 80 upon completion of the intervention (6 weeks)","ALL","18 Years",{"inclusion":51,"exclusion":55,"raw_text":57},[52,53,54],"Adults (≥ 18 years) who are diagnosed with sickle cell disease","Primarily followed at the Massachusetts General Hospital (MGH) Sickle Cell Disease Center","Have ability to comprehend and speak English given Amani is currently only available in English.",[56],"Have severe psychiatric (psychotic disorder, bipoloar disorder) or cognitive impairment which the treating hematologist believes would preclude ability to participate in the clinical trial","Inclusion Criteria:\n\n* Adults (≥ 18 years) who are diagnosed with sickle cell disease\n* Primarily followed at the Massachusetts General Hospital (MGH) Sickle Cell Disease Center\n* Have ability to comprehend and speak English given Amani is currently only available in English.\n\nExclusion Criteria:\n\n* Have severe psychiatric (psychotic disorder, bipoloar disorder) or cognitive impairment which the treating hematologist believes would preclude ability to participate in the clinical trial",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":13,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":77},"Boston","Massachusetts","01867","United States",[68,73,74],{"name":69,"role":70,"phone":71,"email":72},"Richard Newcomb, MD","CONTACT","617-726-2000","richard.newcomb@mgh.harvard.edu",{"role":70,"email":72},{"name":75,"role":76},"Richard A Newcomb, MD","PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},42.35843,-71.05977,[81],{"name":75,"role":70,"phone":71,"email":72},[],[],[],{"nct_id":4,"conditions":86,"biomarkers":87},[19],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]