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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-02-29

Brief Summary

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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

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Detailed Description

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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

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SCD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

No additional parties were masked beyond the outcomes assessor. Only the assessor responsible for measuring clinical outcomes was blinded to group allocation.

Study Groups

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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.

Group Type EXPERIMENTAL

virtual reality

Intervention Type 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)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No