The goal of this clinical trial\] is to study the effectiveness of Virtual Reality (VR) in reducing pain and anxiety during painful procedures for patients with hematological malignancies The main question\[s\] it aims to answer are: Does VR effectively reduce pain during painful procedures for patients with hematological malignancies ? Does VR effectively reduce anxiety during painful procedures for patients with hematological malignancies ? Interventional group (intra-group comparaison): This design allows each patient to act as his own control.: The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session). External control group (inter-group comparaison): Patients will be assigned to the intervention group first, and then a matching external control patient will be selected based on age and type of procedure.
This study is a prospective interventional crossover trial designed to evaluate the efficacy of Virtual Reality during painful procedures, including Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, and chemotherapy. Previous studies have suggested that virtual reality (VR) can distract patients from painful stimuli, enhance the quality of healthcare, and improve overall patient well-being.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
365
Standard care: Standard care. In both the external control group and the intervention group during Period 1, painful procedures will be performed ccording to usual clinical practice by trained healthcare professionals. VR session: The device includes a VR headset connected to a smartphone, which displays immersive visual content, along with headphones that deliver audio content. Scenarios are culturally and demographically adapted to the study population. The duration of each VR session will correspond to the time required for each painful procedure.
Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, Tunisia
Tunis, Sfax Governorate, Tunisia
RECRUITINGChange in pain levels using the Numeric Rating Scale (0-10)
The Numeric rating scale (NRS) of pain is a scale from 0 to 10, where scores from 0 to 3 indicate mild pain, 4 to 6 indicate moderate pain, and 7 to 10 indicate severe pain. The NRS has been proven valid and reliable for measuring cancer-related pain. It will be assessed within 5 minutes before the procedure and within 5 minutes after the procedure during the two periods (standard care, VR session)
Time frame: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure
Change in Anxiety using the Spielberger State-Trait Anxiety Inventory (Y1 and Y2)
The Spielberger Trait Anxiety Inventory measures an individual's general tendency to experience anxiety across various situations. This inventory reflects a stable personality trait, meaning some individuals are more prone to anxiety than others. It will be measured at Baseline The Spielberger State Anxiety Inventory assesses anxiety as a temporary emotional state or condition triggered by a specific situation or stimulus. This scale measures "here and now" anxiety, which can fluctuate in intensity. The STAI-Y1 consists of 20 items, with scores ranging from 20 to 80, evaluated on a 4-point Likert scale (ranging from "Not at all" to "Completely"). Higher scores on both subscales indicate higher levels of anxiety. It will be assessed within 5 minutes before the procedure and within 5 minutes after the procedure during the two periods (standard care and VR session)
Time frame: Trait anxiety: Baseline State anxiety: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure
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