Actively Recruiting
Virtual Reality to Reduce Pain and Anxiety in Hematological Cancer Patients Undergoing Invasive Procedures: Protocol for a Crossover Clinical Trial
Led by Yesmine Amara · Updated on 2025-07-25
365
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yesmine Amara
Lead Sponsor
U
University of Sfax
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how well Virtual Reality (VR) can reduce pain and anxiety during painful procedures in patients with blood cancers, such as hematological malignancies. The study focuses on procedures like Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, and chemotherapy. Previous research suggests VR may help distract patients from pain and improve their overall experience during medical care. The trial uses a crossover design where each patient experiences two periods: one with standard care and one with the addition of a VR session during the same procedure. There is also an external control group receiving only standard care, matched by age and procedure type for comparison. The VR intervention involves a headset connected to a smartphone that displays immersive visual and audio content tailored to the study population. Each VR session lasts as long as the painful procedure. Participants will undergo assessments of pain levels using a Numeric Rating Scale just before and after procedures. Anxiety will be measured with a standardized inventory before and after procedures as well. The study includes a washout period of at least seven days between the two treatment periods. Researchers will monitor how pain and anxiety change with and without VR distraction. The overall participation time varies depending on the procedures and scheduling.
CONDITIONS
Brief Title
Distraction With Virtual Reality From Pain and Anxiety for Patients With Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 6 years old or older
- Have a confirmed diagnosis of a hematological malignancy
- Undergo at least one of the following procedures: Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, or Chemotherapy
You will not qualify if you...
- Have unstable or photosensitive epilepsy
- Have hearing, vision, or inner ear impairments
- Have severe psychiatric, cognitive, or mental disorders
- Have contagious diseases
- Have communication difficulties
- Have withdrawn consent
- Remove the VR headset during the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two periods separated by a washout period of at least 7 days
Participants undergo painful procedures such as Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, or Chemotherapy with and without Virtual Reality distraction to reduce pain and anxiety. The intervention involves wearing a VR headset during the procedure.
2 procedure visits and 1 washout period
Trial Site Locations
Total: 1 location
1
Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, Tunisia
Tunis, Sfax Governorate, Tunisia, 3002
Actively Recruiting
Research Team
Y
Yesmine Amara, PhD student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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