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

NCT ID: NCT07085065

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 365 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-07-31

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.

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.

Conditions

Pain Management; Anxiety; Procedures; Hematological Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

internal control design

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).

Group Type: EXPERIMENTAL

VR session

Intervention Type: 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.

external control group

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.

Group Type: ACTIVE_COMPARATOR

VR session

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Standard care

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sfax

OTHER

Sponsor Role: collaborator

Yesmine Amara

OTHER

Sponsor Role: lead

Responsible Party

Yesmine Amara

Principal Investigator-PhD student

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Tunis, Sfax Governorate, Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Yesmine Amara, PhD student

Role: CONTACT

benmahmoud_lobna@medecinesfax.org

00 216 50 260 564

Facility Contacts

Yesmine Amara (principal investigator), PhD student

Role: primary

yesmine.amara8@gmail.com

00 216 50 260 564

Other Identifiers

FMS-2025-VR1024

Identifier Type: -

Identifier Source: org_study_id