Distraction With Virtual Reality From Pain and Anxiety for Patients With Hematological Malignancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorYesmine Amara
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
unstable or photosensitive epilepsy
hearing, visual, or inner ear impairments
severe psychiatric, cognitive, or mental disorders
Contagious diseases
Trial design
Design model
Crossover
Treatments tested in this trial
VR session
DeviceStandard 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.
Treatment groups
365 Participants
are divided into 2 treatment groupsGroup A: internal control designExperimental treatment 1 intervention
Group B: external control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change 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 procedureSecondary outcomes
1
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 procedureLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, TunisiaRecruiting3002, Tunis, Sfax Governorate
Tunisia
TunisiaSponsors and contacts
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Source ClinicalTrials.gov