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Virtual Reality to Reduce Pain and Anxiety in Hematological Cancer Patients Undergoing Invasive Procedures: Protocol for a Crossover Clinical 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.
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.
Age
6 - No limit years
Sex
ALL
Healthy Volunteers
No
Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, Tunisia
Tunis, Sfax Governorate, Tunisia
Start Date
February 1, 2024
Primary Completion Date
July 31, 2025
Completion Date
July 31, 2025
Last Updated
July 25, 2025
365
ESTIMATED participants
VR session
DEVICE
Lead Sponsor
Yesmine Amara
Collaborators
NCT07478393
NCT07456631
Data Source & Attribution
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