Feasibility and Acceptability of Amani

Feasibilty and Acceptability of Amani, a Virtual Reality Application for Adults With Sickle Cell Disease

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07648043

Acronym

Amani

Enrollment

Registered

2026-06-15

Start date

2026-11-01

Completion date

2028-06-30

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

sickle cell disease, virtual reality, non-pharmacologic analgesia, social support, coping

Brief summary

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.

Interventions

BEHAVIORALAmani

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Have severe psychiatric (psychotic disorder, bipolar disorder) or cognitive impairment which the treating hematologist believes would preclude ability to participate in the clinical trial

Design outcomes

Primary

Measure	Time frame	Description
Feasibility	From enrollment to end of treatment (6 weeks)	Amani will be feasible based on proportion of eligible patients enrolled (≥50% of eligible patients enroll), application educational module completion (≥60% of enrolled participants complete the educational modules) and group intervention attendance (≥60% of Amani group sessions).

Secondary

Measure	Time frame	Description
Acceptability	From enrollment to end of treatment (6 weeks)	Amani will be acceptable if ≥80% enrolled patients report a System Usability Score ≥ 80 upon completion of the intervention (6 weeks)

Countries

United States

Contacts

CONTACTRichard A Newcomb, MD

richard.newcomb@mgh.harvard.edu617-726-2000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026