Impact of Virtual Reality on Pain and Anxiety During Intravenous Cannulation Procedures Among Thalassemia Patients in UAE.

NCT07099196 | Completed

• 1 other identifier: MBRU-IRB-2024-80
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to evaluate the effects of therapeutic Virtual Reality (VR) on pain, anxiety, fatigue and boredom during intravenous (IV) cannulations in comparison to standard of care (SOC).The main question it aims to answer is whether VR can act as an adjuvant for the IV cannulation procedure and improve overall patient experience. Questionnaires were completed after the intravenous cannulation procedure during visits 1, 2 and 3. The Visual Analogue Scale (VAS) was used to assess both primary (pain and anxiety) and secondary (fatigue and boredom) objectives, collecting self-reported data during the three visits. Heart Rate (measured in beats per minute (BPM)) and Blood Pressure (measured in millimeters of mercury (mmHg)) were measured after each procedure

• Participants will come for their routine cannulation and be recruited if willing
• Participants carry out the SOC procedure and are asked to fill out the questionnaires after
• The procedure is carried out with VR at the next appointment after 3-4 weeks
• This is repeated in the next visit

Conditions

Thalassemia, Beta; Thalassemia; Pain; Anxiety; Blood Disorder

Keywords

thalassemia; Beta thalassemia; Virtual Reality; UAE; Pain; Anxiety; Intravenous cannulation; virtual reality therapy; medical hypnosis; digital health

Outcome Measures

Primary Outcomes (2)

• Assessment of Pain using the Visual Analogue Scale

  Self-reported data assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, 0 is equivalent to no pain and 10 indicates the worst possible pain.

  During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.

• Assessment of Anxiety using the Visual Analogue Scale

  Self-reported data assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, Zero is equivalent to no anxiety and 10 indicates the worst possible anxiety.

  During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.

Secondary Outcomes (5)

• Assessment of Fatigue using the Visual Analogue Scale

  During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.

• Assessment of Boredom using the Visual Analogue Scale

  During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.

• Assessment of Patient Satisfaction

  During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.

• Blood Pressure (mmHg)

  After the cannulation procedure, at each clinic visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.

• Heart Rate (BPM)

  After the cannulation procedure, at each clinic visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.

Study Arms (1)

Thalassemia patients

EXPERIMENTAL

This arm acts as its own control, with participants receiving SOC for their first visit, and then receiving VR for their next 2 visits during their cannulation procedure.

Device: Headset-based Virtual Reality Simulation

Interventions

Headset-based Virtual Reality Simulation DEVICE

The device used was a HEALTHY-MIND© PICO G2 Virtual Reality headset, which is medically graded and suited for distraction and relaxation in clinical settings.

Also known as: Medical Hypnosis, Relaxation Tool, virtual reality, therapeutic virtual reality

Thalassemia patients

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of thalassemia
• Thalassemia patients undergoing intravenous cannulation procedure
• Patients aged \>7 years (male, female, adult, pediatrics, national and non-national) at the Dubai Thalassemia Center

You may not qualify if:

• Pregnant or nursing women
• Patients of legal age but subject to legal protection measures or unable to express their consent
• Patients suffering from uncontrolled epilepsy
• Patients with visual or auditory disorders
• Patients suffering from claustrophobia or motion sickness
• Patients with face infections
• Patients with dissociative psychiatric pathologies and/or autism

Sponsors & Collaborators

• Mohammed Bin Rashid University of Medicine and Health Sciences: lead

Study Sites (1)

Dubai Thalassemia Center

Dubai, United Arab Emirates

Location

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MeSH Terms

Conditions

beta-Thalassemia; Thalassemia; Pain; Anxiety Disorders; Hematologic Diseases

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Student

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: August 1, 2025
• Study Start: May 24, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)