Virtual Reality and Congenital Diaphragmatic Hernia

Not Applicable

Completed

• Conditions: Virtual Reality; Congenital Diaphragmatic Hernia; Children

• Registration Number: NCT05612503
• Lead Sponsor: Qassim University

Brief Summary

The study has been designed to investigate the effect of 12 weeks of using virtual reality based exercises on pulmonary functions, exercise capacity, functional performance, and quality of life in children with surgically-repaired congenital diaphragmatic hernia.

Detailed Description

Children with CDH have significant disruptions in their quality of life (QoL) due to their poor health, in this randomized controlled clinical trial, one important aspect of virtual reality is the interactivity of children and their interests in choosing the exercised game. Each child in two groups perform a specific virtual reality based respiratory exercises for 3 months.

Study Timeline

• Study Start: 2021-01-10
• Primary Completion: 2021-09-09
• Study Completion: 2022-04-15
• Study First Submitted: 2022-10-27
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• age between 6 and 10 years.
• BMI was between 20 and 24 kg/m2.
• surgically-repaired congenital diaphragmatic hernia.
• respiratory distress symptoms.
• under follow-up care in pediatric and physical therapy clinic.

Exclusion Criteria

• Children were excluded if they have growth abnormality.
• neuromotor disorders.
• children with cardiac problems.
• unable to do understand all procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulmonary function test, forced vital capacity	after 12 weeks	A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Pulmonary function test, forced expiratory volume in the first second	after 12 weeks	A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Pulmonary function test, FEV1/FVC ratio	after 12 weeks	performed using a spirometer (Autospiro-507; Minato Medical Science; Osaka. Japan)., (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
Exercise capacity assessment	after 12 weeks	Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.

Secondary Outcome Measures

Name	Time	Method
Functional performance assessment	after 12 weeks	Functional performance was assessed through using the 6-min walk test.
Pediatric Quality of Life Inventory	after 12 weeks	Quality of life was evaluated using self-report Pediatric Quality of Life Inventory (PedsQL), it is multidimensional measures of HRQL in children and adolescents, it includes 23 items distributed among 4 domains \[physical (8 items) , emotional( 5 items), social ( 5 items ), and school functions ( 3 items )\] including 23 items. It provides child self-report and parents report with 5- points scale ( 0 means never, and 4 means almost always).

Trial Locations

Locations (1)

Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University; 🇸🇦 Al-Kharj, Riyadh, Saudi Arabia