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

• Sponsor: Afnan Bkri (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05952817
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 2.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Blood Disease	Device: virtual reality; Procedure: Physical Exercise	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: control group,i ntervention groupcontrol group,i ntervention group
• Masking: Single (Participant)
• Masking Description: children with Blood diseases
• Primary Purpose: Treatment
• Official Title: The Effect of Virtual Reality on Pain and Musculoskeletal Dysfunction in Children With Sickle Cell Disease: A Randomized Controlled Trial
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Sep 9, 2023
• Anticipated Study Completion Date: Oct 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: virtual reality treatment Virtual reality treatment	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)
Other: Exercise programs Congenital physical therapy exercise	Procedure: Physical Exercise; Rehabilitation program of exercise

Outcome Measures

Primary Outcome Measures

1. The Wong-Baker Pain Faces Scale [6. weeks]

   pain

Secondary Outcome Measures

1. The PedsQL™ [6 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Afnan Bkri

Investigators

• Study Director: afaf shaheen shaheen, PHD, King Saud University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Afnan Bkri, Physiotherapist, Ministry of Health, Saudi Arabia
• ClinicalTrials.gov Identifier: NCT05952817
• Other Study ID Numbers: MohSaudiArabia1
• First Posted: Jul 19, 2023
• Last Update Posted: Jul 19, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Afnan Bkri, Physiotherapist, Ministry of Health, Saudi Arabia: Virtual reality ,SCD, physiotherapy , rehabilitatation , pediatric, Blood diseases
• Additional relevant MeSH terms: Anemia, Sickle Cell; Hematologic Diseases

Study Results

No Results Posted as of Jul 19, 2023