Physiotherapy for Children With Sickle Cell Disease: A Randomized Controlled Trial

Blood Disease Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05952817
• Other study ID #: MohSaudiArabia1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: July 2023
• Source: Ministry of Health, Saudi Arabia
• Contact: Afnan ahmed Bkri, Bachelor
• Phone: 0583774624
• Email: bkriafnan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary aim to determine the effects of immersive VR on pain management in children with SCD. Secondary aim to determine the effects of immersive VR in musculoskeletal dysfunction in children with SCD and health-related quality of life.

Description:

We hypothesized that: 1. Immersive VR would significantly improve pain in children with SCD. 2. Immersive VR would significantly improve musculoskeletal function in children with SCD. 3. Immersive VR would significantly improve the health quality of life according to children.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 20, 2023
• Est. primary completion date: September 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria are as following: patients aged between 6-18 years of both genders diagnosed with SCD, with hip avascular necrosis (AVN), with joints pain, children with SCD post hip surgery, with motor impairment and gait difficulty, with restricted ROM in lower limb, children with recent crisis of SCD.

Exclusion Criteria:

• The exclusion criteria are the children with previous stroke or other neurologic disorders and cardiopulmonary disorders that limits the functional activities of the participants will be excluded.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Blood Disease
• Hematologic Diseases

Intervention

Device:
• 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)

Procedure:
• Physical Exercise
Rehabilitation program of exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Afnan Bkri

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Wong-Baker Pain Faces Scale	pain	6. weeks
Secondary	The PedsQL™	The PedsQL™ measurement model was designed as a modular approach to measuring pediatric health-related quality of life and developed to integrate the relative merits of generic and disease-specific approaches. The PedsQL™ has demonstrated reliability, validity, sensitivity, and responsiveness for child	6 weeks