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

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

Study Overview

• Status: Completed
• Conditions: SCD
• Intervention / Treatment: Device: virtual reality

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jazan, Saudi Arabia, 45142
    • Prince Mohammed bin Nasser Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality treatment; 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; 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)
No Intervention: Standard Care Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 3, and Week 5
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.	Baseline, Week 3, and Week 5

Collaborators and Investigators

• Sponsor: Afnan Bkri
• Investigators: Study Director: afaf Ah shaheen, PHD, King Saud University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 15, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Children; Randomized Controlled Trial; Virtual Reality; Functional Mobility; Sickle Cell Disease; Health-Related Quality of Life; Numeric Rating Scale
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: MohSaudiArabia1; Jazan health cluser ethics com (Other Identifier: R/N(H-10-Z-141))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Study Data/Documents

1. Statistical Analysis Plan
   Information identifier: PMID: 11561673

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No