Effect of Virtual Reality on Pain, Arterial Blood Gases and Functional Capacity in Children After Open Heart Surgery

This study will be conducted to investigate:

• The effect of virtual reality on pain in children after open heart surgery,
• The effect of virtual reality on arterial blood gases in children after open heart surgery,
• The effect of virtual reality on functional capacity in children after open heart surgery.

Study Overview

• Status: Completed
• Conditions: Children After Open Heart Surgery
• Intervention / Treatment: Other: Designed cardiac physical therapy program; Device: virtual reality glasses

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • National Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Both genders will be included.
• Their age range from 6 to 12 years.
• Children after open heart surgery ( phase I cardiac rehabilitation).

Exclusion Criteria:

The children have one or more of the following will be excluded:

• Any child Suffering from any other chronic congenital diseases.
• Severe visual or auditory problems.
• Neurological problems.
• Vertigo problems.
• Post surgical hemorrhage.
• Post surgical arrhythmia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Designed cardiac physical therapy program ( study group ); Designed cardiac physical therapy program	Other: Designed cardiac physical therapy program; Designed cardiac physical therapy program without virtual reality glasses
Experimental: virtual reality group (study group); virtual reality glasses Designed cardiac physical therapy program applied through virtual reality glasses for study group	Device: virtual reality glasses; Designed cardiac physical therapy program applied through virtual reality glasses for study group; Other Names: Experimental: study group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial blood gases	Arterial Blood Gases Analysis to detect blood gases	1 hour /session 1 time / day for 5 consecutive days
functional capacity	The Six-Minute Walk Test (6MWT) for assessment functional capacity	1 hour /session 1 time / day for 5 consecutive days
pain level	Pain level assessment by Wong-Baker faces scale:	1 hour /session 1 time / day for 5 consecutive days

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2024
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: virtual reality, heart surgery
• Other Study ID Numbers: P.T.REC/012/005353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes