RecruitingNot ApplicableNCT07085065

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


Sponsor

Yesmine Amara

Enrollment

365 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether virtual reality (VR) headsets can reduce pain and anxiety in children and adults with blood cancers during painful medical procedures such as bone marrow biopsies, spinal taps, or blood draws. **You may be eligible if...** - You are 6 years or older - You have a confirmed diagnosis of a blood cancer (such as leukemia, lymphoma, or myeloma) - You are undergoing at least one of these procedures: bone marrow biopsy or aspiration, lumbar puncture (spinal tap), blood draw, or chemotherapy infusion **You may NOT be eligible if...** - You have epilepsy that is triggered by flashing lights or is unstable - You have significant hearing, vision, or inner ear problems - You have severe psychiatric or cognitive disorders - You have a contagious infection - You have communication difficulties that prevent study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEVR 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.


Locations(1)

Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, Tunisia

Tunis, Sfax Governorate, Tunisia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07085065


Related Trials