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

NCT05952817 | Completed

• 2 other identifiers: MohSaudiArabia1Jazan health cluser ethics com
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

SCD

Keywords

Sickle Cell Disease; Virtual Reality; Numeric Rating Scale; Randomized Controlled Trial; Children; Health-Related Quality of Life; Pain; Functional Mobility

Outcome Measures

Primary Outcomes (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.

  Baseline, Week 3, and Week 5

Secondary Outcomes (2)

• Health-Related Quality of Life (PedsQL)

  Baseline, Week 3, and Week 5

• Functional Mobility (Timed Up and Go Test - TUG)

  Baseline, Week 3, and Week 5

Study Arms (2)

virtual reality treatment

EXPERIMENTAL

Participants 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.

Device: virtual reality

Standard Care Group

NO INTERVENTION

Participants 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.

Interventions

virtual reality DEVICE

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)

virtual reality treatment

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Afnan Bkri: lead

Study Sites (1)

Prince Mohammed bin Nasser Hospital

Jizan, 45142, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 30362236 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; 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

Study Officials

• afaf Ah shaheen, PHD

  King Saud University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No additional parties were masked beyond the outcomes assessor. Only the assessor responsible for measuring clinical outcomes was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: September 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 29, 2024
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) and supporting documents will be made available beginning 6 months after publication of the main findings. Data will remain accessible for up to 3 years following the date of publication.
• Access Criteria: Qualified researchers affiliated with academic institutions or healthcare organizations may request access to de-identified IPD and supporting documents (study protocol, SAP, CSR, and analytic code). Requests must include a data use agreement and be reviewed and approved by the institutional ethics committee. Approved data will be shared securely via institutional platforms or encrypted file transfer.

Locations

SA (1)