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

NCT07085065 | Recruiting

• 1 other identifier: FMS-2025-VR1024
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Virtual Reality; Pain; Anxiety; Hematological Malignancies; Invasive procedures; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Change in pain levels using the Numeric Rating Scale (0-10)

  The Numeric rating scale (NRS) of pain is a scale from 0 to 10, where scores from 0 to 3 indicate mild pain, 4 to 6 indicate moderate pain, and 7 to 10 indicate severe pain. The NRS has been proven valid and reliable for measuring cancer-related pain. It will be assessed within 5 minutes before the procedure and within 5 minutes after the procedure during the two periods (standard care, VR session)

  Assessed within 5 minutes before the procedure and within 5 minutes after the procedure

Secondary Outcomes (1)

• Change in Anxiety using the Spielberger State-Trait Anxiety Inventory (Y1 and Y2)

  Trait anxiety: Baseline State anxiety: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure

Study Arms (2)

internal control design

EXPERIMENTAL

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).

Device: VR session

external control group

ACTIVE COMPARATOR

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.

Device: VR session

Interventions

VR session DEVICE

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.

Also known as: Standard care

external control group; internal control design

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yesmine Amara: lead
• University of Sfax: collaborator

Study Sites (1)

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

Tunis, Sfax Governorate, 3002, Tunisia

RECRUITING

MeSH Terms

Conditions

Agnosia; Anxiety Disorders; Hematologic Neoplasms; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Yesmine Amara, PhD student

CONTACT

00 216 50 260 564; benmahmoud_lobna@medecinesfax.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator-PhD student

Model Details: 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). In addition to this internal control design, the study will also include an external control group consisting 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.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 25, 2025
• Study Start: February 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)