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

NCT07085065 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

  • Pain Management
  • Anxiety
  • Procedures
  • Hematological Neoplasms

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 correspond to the time required for each painful procedure.

Sponsors & Collaborators

  • University of Sfax

    collaborator OTHER

  • Yesmine Amara

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Tunisia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085065 on ClinicalTrials.gov