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

Afnan Bkri

Status: Completed

Conditions: SCD

Treatments: Device: virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05952817

MohSaudiArabia1

Jazan health cluser ethics com (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

virtual reality treatment

Experimental group

Description:

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.

Treatment:

Device: virtual reality

Standard Care Group

No Intervention group

Description:

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.