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NCT05952817Completed

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

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

Source: ClinicalTrials.gov · Last updated 18 Jun 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
40 (actual)
First submitted
11 Jul 2023
Start date
1 Sept 2023
Primary completion date
1 Feb 2024
Lead sponsor
Afnan Bkri
NCT number
NCT05952817

What you commit to

  • Study type: Interventional
  • Participants enrolled: 40
  • From 1 Sept 2023 to the primary completion date, 1 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in concurrent physiotherapy or rehabilitation programs.
  • Previously enrolled in phase one of the current study (if applicable)

Other illness

  • Presentence of developmental, neurological, or genetic disorders.
  • History of hip replacement or major orthopedic conditions affecting mobility.
  • Current acute chest syndrome or unstable clinical condition.

Other

  • Visual or hearing impairments that would interfere with VR use.

Who the study is looking for

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

Age in the registry: 8 years to 13 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Prince Mohammed bin Nasser Hospital
Coordinator of this site? Confirm its status
JizanSaudi ArabiaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.