Trials / Completed
CompletedNCT05354414
Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy
A Randomized Crossover Pragmatic Study to Evaluate Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Patients With Spinal Muscular Atrophy. REALITY Study.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 7 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate anxiety level during intrathecal administration (IT) under standard of care (SOC) and virtual reality (VR) conditions using a reliable self-rating scale.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Virtual reality | Administered as specified in the treatment arm. |
| PROCEDURE | Standard of Care | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2022-05-11
- Primary completion
- 2024-07-12
- Completion
- 2024-07-12
- First posted
- 2022-04-29
- Last updated
- 2025-04-02
Locations
12 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05354414. Inclusion in this directory is not an endorsement.