SCD
Conditions
Keywords
Sickle Cell Disease, Virtual Reality, Numeric Rating Scale, Randomized Controlled Trial, Children, Health-Related Quality of Life, Pain, Functional Mobility
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
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
Interventions
DEVICEvirtual 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)
Sponsors
Afnan Bkri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
No additional parties were masked beyond the outcomes assessor. Only the assessor responsible for measuring clinical outcomes was blinded to group allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (Numeric Rating Scale - NRS) | Baseline, Week 3, and Week 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life (PedsQL) | Baseline, Week 3, and Week 5 | 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. |
| Functional Mobility (Timed Up and Go Test - TUG) | Baseline, Week 3, and Week 5 | 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. |
Countries
Saudi Arabia
Outcome results
None listed