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

Yesmine Amara

Status: Enrolling

Conditions: Hematological Neoplasms; Procedures; Pain Management; Anxiety

Treatments: Device: VR session

Study type: Interventional

Funder types: Other

Identifiers

NCT07085065

FMS-2025-VR1024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 365 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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365 participants in 2 patient groups

internal control design

Experimental group

Description:

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 during the same procedure).

Treatment:

Device: VR session

external control group

Active Comparator group

Description:

This arm consists of patients who will receive only standard care throughout the study. These external control participants will be matched to the interventional group based on age and procedure type, ensuring comparability between groups.

Treatment:

Device: VR session