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Recruiting NCT07085065

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

No phase Interventional Pain Management Anxiety Procedures Hematological Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR session.
Who it may be relevant to
Registry conditions: Pain Management, Anxiety, Procedures, Hematological Neoplasms. Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Tunisia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 co

Primary outcome measures

  • Change in pain levels using the Numeric Rating Scale (0-10) [Time frame: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure]
Secondary outcome measures (1)
  • Change in Anxiety using the Spielberger State-Trait Anxiety Inventory (Y1 and Y2) [Time frame: Trait anxiety: Baseline State anxiety: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Single blind
Primary purpose
Supportive care

Study locations

Tunisia · 1 center
  • Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, Tunisia — Tunis

Identifiers

NCT: NCT07085065 · FMS-2025-VR1024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗