Virtual reality to distract from pain and anxiety during blood cancer procedures
Virtual Reality to Reduce Pain and Anxiety in Hematological Cancer Patients Undergoing Invasive Procedures: Protocol for a Crossover Clinical Trial
This project tries whether wearing a virtual reality headset during procedures can reduce pain and anxiety for people aged 6 and older with blood cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 365 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | University of Sfax Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Tunis, Sfax Governorate) |
| Trial ID | NCT07085065 on ClinicalTrials.gov |
What this trial studies
This is a prospective interventional crossover trial where each participant first receives standard care during a procedure, has at least a seven-day washout, and then repeats the procedure with a VR session so each patient can act as their own control; an external matched-control group by age and procedure type is also included. Procedures covered include bone marrow biopsy and aspiration, lumbar puncture, venipuncture, and some chemotherapy visits. The intervention is a VR session delivered during the procedure intended to distract patients and lower perceived pain and anxiety. Outcomes compare patient-reported pain and anxiety between the standard-care and VR sessions.
Who should consider this trial
Good fit: Ideal candidates are people aged 6 or older with a confirmed hematologic malignancy who will undergo bone marrow biopsy/aspiration, lumbar puncture, venipuncture, or chemotherapy.
Not a fit: Patients with unstable or photosensitive epilepsy, significant hearing/visual/inner-ear impairments, severe psychiatric or cognitive disorders, active contagious diseases, communication difficulties, or those who remove the VR headset during the procedure may not receive benefit.
Why it matters
Potential benefit: If successful, VR could lower pain and anxiety during invasive procedures and make those visits more comfortable for patients with hematologic malignancies.
How similar studies have performed: Previous smaller studies in other clinical settings have shown that VR can reduce procedure-related pain and anxiety, but high-quality data specifically in hematologic malignancy procedures remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tunis, Sfax Governorate
- Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, Tunisia — Tunis, Sfax Governorate, Tunisia (Recruiting)
Study contacts
- Study coordinator: Yesmine Amara, PhD student
- Email: benmahmoud_lobna@medecinesfax.org
- Phone: 00 216 50 260 564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.