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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorYesmine Amara

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

unstable or photosensitive epilepsy

hearing, visual, or inner ear impairments

severe psychiatric, cognitive, or mental disorders

Contagious diseases

Trial design

Treatments tested in this trial

  • VR session

Treatment groups

365 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, TunisiaRecruiting3002, Tunis, Sfax GovernorateTunisiaTunisia

Sponsors and collaborators

Yesmine Amara

Lead sponsor

University of Sfax

Sponsor institution

University of Sfax

Collaborator