NCT07085065

Distraction With Virtual Reality From Pain and Anxiety for Patients With Hematological Malignancies

Virtual Reality to Reduce Pain and Anxiety in Hematological Cancer Patients Undergoing Invasive Procedures: Protocol for a Crossover Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 365 (estimated)
• Sponsor: Yesmine Amara · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain Management
• Anxiety
• Procedures
• Hematological Neoplasms

Interventions

Type	Name	Description
DEVICE	VR 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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: Tunisia