Clinical trial NCT05952817: Effect of Virtual Reality on Pain and Function in Children With Sickle Cell Disease: A Randomized Controlled Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SCD
Keywords: Sickle Cell Disease
Virtual Reality
Numeric Rating Scale
Randomized Controlled Trial
Children
Health-Related Quality of Life
Pain
Functional Mobility
Lead sponsor: Ministry of Health, Saudi Arabia
Sponsor class: OTHER_GOV
First posted: 2023-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Pain Intensity (Numeric Rating Scale - NRS)
timeFrame: Baseline, Week 3, and Week 5
Secondary outcomes:
measure: Health-Related Quality of Life (PedsQL)
timeFrame: Baseline, Week 3, and Week 5
measure: Functional Mobility (Timed Up and Go Test - TUG)
timeFrame: Baseline, Week 3, and Week 5
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Prince Mohammed bin Nasser Hospital
Study officials:
affiliation: King Saud University
name: afaf Ah shaheen, PHD
role: STUDY_DIRECTOR
References:
citation: 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.