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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
63
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.
Chu d' Angers
Angers, France
CHRU de Brest
Brest, France
Chu de Clermont Ferrand
Clermont-Ferrand, France
APHP- Raymond Poincaré Paris
Garches, France
Visual Analog Scale for Anxiety (VAS-A) Score During IT as Evaluated by the Participant Just After IT
The VAS-A scale is used in the assessment of anxiety. The 101-point scale (0 to 100) is a horizontal 100 millimeter (mm) line that starts with no anxiety on the left and ends with maximum anxiety on the right. The VAS score is determined by measuring in mm from the left-hand end of the line to the point that the participant marks. High scores on the scale indicate that anxiety is high.
Time frame: Up to 450 days
Blood Pressure Before and After IT
Systolic and diastolic blood pressures will be assessed.
Time frame: Up to 450 days
Heart Rate Before and After IT
Time frame: Up to 450 days
Short State-Trait Anxiety Inventory (Short STAI) Score During IT as Evaluated by the Participant Just After IT
The 6-item short form of the Spielberger STAI is used to measure self-reported symptoms of state anxiety. It consists of 6 questions each having scale 1 (Almost Never) to 4 (Almost Always). The score range for the short STAI is 6 to 24 points, with 6 points signifying no anxiety and 24 points signifying the highest level of anxiety.
Time frame: Up to 450 days
Number of Participants With Use of Medication/Intervention for Anxiety and Pain Management Before, During and up to 72 hour (h) After IT
Time frame: Up to 450 days
Visual Analog Scale for Pain (VAS-P) Score Just After IT
The VAS-P scale is used in the assessment of pain. The 101 point scale (0 to 100) is a horizontal 100 mm line that starts with no pain on the left and ends with maximum pain on the right. The VAS score is determined by measuring in mm from the left hand end of the line to the point that the participant marks. High scores indicate worse pain.
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Chu de Lille
Lille, France
CHU Montpellier
Montpellier, France
CHU de Nancy
Nancy, France
Chu de Nice
Nice, France
APHP- Necker Paris
Paris, France
APHP- Trousseau Paris
Paris, France
...and 2 more locations
Time frame: Up to 450 days
Maximal VAS-P Score Within 72h of IT
The VAS-P scale is used in the assessment of pain. The 101 point scale (0 to 100) is a horizontal 100 mm line that starts with no pain on the left and ends with maximum pain on the right. The VAS score is determined by measuring in mm from the left hand end of the line to the point that the participant marks. High scores indicate worse pain.
Time frame: Up to 450 days
Number of Participants With Satisfactory Experience of Using VR, Desire to Continue IT, Desire to Continue VR
Participants will be asked to complete a satisfaction survey to evaluate his/her experience. It is a questionnaire consisting of 6 (for age \>12 years) to 7 (for age \<12 years) questions.
Time frame: Up to 150 days
Number of Participants With Satisfactory Experience of Using VR, as Assessed by Custom Care Team
The custom care team will be asked to complete a satisfaction survey to evaluate participant's experience. It is a questionnaire consisting of 5 questions.
Time frame: Up to 150 days