Skip to main content
OpenTrials
Completed

NCT Number: NCT05952817

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SCD Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince Mohammed bin Nasser Hospital

Jizan, 45142, Saudi Arabia

About this study

  • To investigate the effect of VR in reducing daily pain in children with SCD
  • To evaluate the impact of VR on improving functional mobility in children with SCD.
  • To examine the changes in PedsQL in children with SCD after engaging in VR experiences.
  • To evaluate the safety and satisfaction of fully immersive VR therapy in children with

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Visual or hearing impairments that would interfere with VR use.
  • Participation in concurrent physiotherapy or rehabilitation programs.
  • Previously enrolled in phase one of the current study (if applicable)

Treatment and study plan

Virtual reality

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)

Primary outcomes

  1. Pain Intensity (Numeric Rating Scale - NRS)

    Time frame: 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 outcomes

  1. Health-Related Quality of Life (PedsQL)

    Time frame: 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.

  2. Functional Mobility (Timed Up and Go Test - TUG)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Afnan Bkri

Other Gov

Registry information

Official study 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

Acronym: RCT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2023
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.