Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07085065

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pain Management Agnosia Anxiety Anxiety Disorders Hematologic Diseases Hematologic Neoplasms Hematological Neoplasms Hemic and Lymphatic Diseases Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Procedures Signs and Symptoms

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tunis, Sfax Governorate, 3002, Tunisia

Location status: Recruiting

Location contact

Yesmine Amara (principal investigator), PhD student

CONTACT

[email protected]

00 216 50 260 564

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Standard care

Primary outcomes

  1. 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

    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)

Secondary outcomes

  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

    The Spielberger Trait Anxiety Inventory measures an individual's general tendency to experience anxiety across various situations. This inventory reflects a stable personality trait, meaning some individuals are more prone to anxiety than others. It will be measured at Baseline The Spielberger State Anxiety Inventory assesses anxiety as a temporary emotional state or condition triggered by a specific situation or stimulus. This scale measures "here and now" anxiety, which can fluctuate in intensity. The STAI-Y1 consists of 20 items, with scores ranging from 20 to 80, evaluated on a 4-point Likert scale (ranging from "Not at all" to "Completely"). Higher scores on both subscales indicate higher levels of anxiety. It will be assessed within 5 minutes before the procedure and within 5 minutes after the procedure during the two periods (standard care and VR session)

Study contacts

Contact information is provided by the study sponsor or research team.

Yesmine Amara, PhD student

CONTACT

[email protected]

00 216 50 260 564

Sponsors and collaborators

Lead sponsor

Yesmine Amara

Other

Collaborators

  • University of Sfax

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.