Anxiety, Hematological Neoplasms, Pain Management, Procedures
Conditions
Keywords
Virtual Reality, Pain, Anxiety, Hematological Malignancies, Invasive procedures, Chemotherapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEVR session
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.
Sponsors
University of Sfax
Yesmine Amara
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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). In addition to this internal control design, the study will also include an external control group consisting of patients who will receive only standard care throughout the study. These external control participants will be matched to the interventional group based on age and procedure type, ensuring comparability between groups.
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* being ≥ 6 years old * having a confirmed diagnosis of a hematological malignancy * undergoing at least one of the following procedures: Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, or Chemotherapy.
Exclusion criteria
* unstable or photosensitive epilepsy * hearing, visual, or inner ear impairments * severe psychiatric, cognitive, or mental disorders * Contagious diseases * Communication difficulties * Patients who withdraw consent * Patient who remove the VR headset during the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain levels using the Numeric Rating Scale (0-10) | Assessed within 5 minutes before the procedure and within 5 minutes after the procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety using the Spielberger State-Trait Anxiety Inventory (Y1 and Y2) | Trait anxiety: Baseline State anxiety: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure | 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) |
Countries
Tunisia
Contacts
Primary ContactYesmine Amara, PhD student
Outcome results
None listed