Distraction With Virtual Reality From Pain and Anxiety for Patients With Hematological Malignancies
Recruiting · NCT07085065 · Interventional (participants receive a specific treatment) · Lead sponsor: Yesmine Amara
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, Tunisia - Tunis, Sfax Governorate, Tunisia