AzTrials
AzTrials

SCDRCTNCT05952817

Effect of Virtual Reality on Pain and Function in Children With Sickle Cell Disease: A Randomized Controlled Trial

A study testing virtual reality in people with SCD, run by Afnan Bkri at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Significance or rationale of the study: Virtual reality (VR) is a promising non-pharmacological pain management tool. It enhances motor function by promoting cortical reorganization and neuroplasticity. Read more about this study

Who is it for?
Ages 8 to 13 years
Conditions the study is for
SCD
What is being tested?
virtual reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSaudi Arabia
Study dates
1 Sep 2023to 29 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged between 8 and 13 years.
  • Diagnosed with sickle cell disease (SCD), including homozygous SCA and other clinically confirmed variants.
  • Medically stable and cleared by the treating physician to participate in mild activity.
  • Receiving hydroxyurea as part of routine care.
  • Able to follow simple instructions and communicate pain levels.
  • Parental/legal guardian consent and child assent obtained.

Who cannot join

  • Presentence of developmental, neurological, or genetic disorders.
  • History of hip replacement or major orthopedic conditions affecting mobility.
  • Current acute chest syndrome or unstable clinical condition.
  • Visual or hearing impairments that would interfere with VR use.
  • Participation in concurrent physiotherapy or rehabilitation programs.
  • Previously enrolled in phase one of the current study (if applicable)

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • Prince Mohammed bin Nasser Hospital

    Jizan, 45142

Other trials in Saudi Arabia

About this study

Official title: The Effect of Virtual Reality on Pain, Physical Function, and Health-related Quality of Life in Children With Sickle Cell Disease: A Randomized Controlled Trial

Significance or rationale of the study:

Virtual reality (VR) is a promising non-pharmacological pain management tool. It enhances motor function by promoting cortical reorganization and neuroplasticity. Its multimodal biofeedback engages sensory and cognitive functions, making therapy interactive, motivating, and easy to understand. With strong rehabilitation potential, VR helps patients adapt to real-world movements (Laver, 2020). Initially used for procedural pain management, VR is now expanding into chronic pain rehabilitation by encouraging engagement with difficult or avoided movements (Griffin et al., 2020). Additionally, VR offers a dynamic alternative to traditional exercises, improving adherence and outcomes. Integrating entertainment into therapy can motivate children, enhancing their physical and psychological well-being. Recently, a few studies revealed an improvement in vaso-occlusive episodes (VOE) after VR treatment (Agrawal et al., 2019). However, efficacy studies are needed to assess VR's potential benefits. Additionally, data regarding VR's efficacy on daily pain, functional mobility, and HRQOL as complementary therapy are limited

Read the detailed description
  1. To investigate the effect of VR in reducing daily pain in children with SCD
  2. To evaluate the impact of VR on improving functional mobility in children with SCD.
  3. To examine the changes in PedsQL in children with SCD after engaging in VR experiences.
  4. To evaluate the safety and satisfaction of fully immersive VR therapy in children with
Conditions
SCD
Being tested
virtual reality
Keywords
Sickle Cell Disease, Virtual Reality, Numeric Rating Scale, Randomized Controlled Trial, Children, Health-Related Quality of Life, Pain, Functional Mobility
Medical subject headings
Anemia, Sickle Cell, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtual realityDevice

    Virtual reality (VR) technology is a new medical intervention technique founded on the principle of distraction, providing real perceptual stimuli such as visual images, spatial sounds, tactile, and sensory feedback stimuli.(Zhang et al., 2022)

Study groups in NCT05952817
Study groupRoleWhat they receive
virtual reality treatmentExperimentalParticipants assigned to this arm received a fully immersive virtual reality (VR) exercise program. The intervention consisted of a series of interactive physical therapy games designed to improve functional mobility, joint movement, balance, and pain management. Sessions were conducted at home over five weeks using an Oculus Quest 2 headset and KindVR Aqua software. Each session lasted 15 minutes and was supervised weekly by a pediatric physical therapist through follow-up communication.
Receives: Device: virtual reality
Standard Care GroupNo interventionParticipants in this group received standard care without any additional VR-based interventions. They continued with their usual medical management and home routines as prescribed by their healthcare providers. No structured exercise or virtual therapy was provided during the study period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity (Numeric Rating Scale - NRS)

    Pain intensity was assessed using the validated Arabic version of the Numeric Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Participants were asked to rate their pain immediately before and after the VR session to measure the short-term analgesic effect of the intervention.

    Measured: Baseline, Week 3, and Week 5

Secondary outcomes (2)

  1. Health-Related Quality of Life (PedsQL)

    The Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale was used to assess health-related quality of life in children aged 8-13 years. The Arabic validated version was administered at baseline, mid-intervention (week 3), and post-intervention (week 5). Higher scores indicate better quality of life across physical, emotional, social, and school functioning domains.

    Measured: Baseline, Week 3, and Week 5

  2. Functional Mobility (Timed Up and Go Test - TUG)

    Functional mobility was measured using the Timed Up and Go (TUG) test. Participants were instructed to rise from a chair, walk 3 meters, turn around, walk back, and sit down. The total time taken to complete the task was recorded in seconds. Assessments were conducted at baseline, week 3, and week 5.

    Measured: Baseline, Week 3, and Week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start1 Sep 2023
  3. Primary completion1 Feb 2024
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned into two parallel groups following hospital discharge. The intervention group received a virtual reality (VR) program consisting of multiple sessions delivered over five weeks, while the control group continued with usual care. Both groups were followed at regular intervals, and outcome measures including pain intensity, physical function (Timed Up and Go), and health-related quality of life (PedsQL) were assessed at baseline, week 3, and week 5. The design followed a parallel assignment model without crossover between groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05952817
Sponsor's protocol ID
MohSaudiArabia1
Other IDs
Jazan health cluser ethics com
Acronym
RCT
Status last verified
Jun 2025
First submitted
11 Jul 2023
Last updated
18 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified IPD including pain scores and outcome measures will be available upon reasonable request with appropriate ethical approval. De-identified individual participant data (IPD), including pain scores and functional outcomes, will be made available upon reasonable request. Supporting documents such as the study protocol, statistical analysis plan, clinical study report, and analytic code will also be provided. Data will be shared through institutional data-sharing agreements and with approval from the responsible ethics committee. Availability is expected within 6 months following publication.

Publications

  • Agrawal AK, Robertson S, Litwin L, Tringale E, Treadwell M, Hoppe C, Marsh A. Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. Pediatr Blood Cancer. 2019 Feb;66(2):e27525. doi: 10.1002/pbc.27525. Epub 2018 Oct 26.

    PubMed 30362236

  • Hassan Bakri AA, Algabbani MF, Farrag A, Elsayed W, Rezk MZA, Bindawas SM, Alhusaini AA, Shaheen AAM. Effect of fully immersive virtual reality on daily pain, functional mobility, and health-related quality of life in pediatric sickle cell disease: a single-blinded randomized clinical trial. Disabil Rehabil. 2026 Feb 10:1-15. doi: 10.1080/09638288.2026.2625551. Online ahead of print.

    PubMed 41664928

Questions about this trial

What is this clinical trial studying?

A study testing virtual reality in people with SCD, run by Afnan Bkri at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (Numeric Rating Scale - NRS) (time frame: Baseline, Week 3, and Week 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05952817, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in