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

NCT06712368 | Completed DMC FDA Device

• 1 other identifier: P.T.REC/012/005353
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Children After Open Heart Surgery

Keywords

virtual reality, heart surgery

Outcome Measures

Primary Outcomes (3)

• pain level

  Pain level assessment by Wong-Baker faces scale:

  1 hour /session 1 time / day for 5 consecutive days

• 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

Study Arms (2)

Designed cardiac physical therapy program ( study group )

ACTIVE COMPARATOR

Designed cardiac physical therapy program

Other: Designed cardiac physical therapy program

virtual reality group (study group)

EXPERIMENTAL

virtual reality glasses Designed cardiac physical therapy program applied through virtual reality glasses for study group

Interventions

virtual reality glasses DEVICE

Designed cardiac physical therapy program applied through virtual reality glasses for study group

Also known as: Experimental: study group

Designed cardiac physical therapy program OTHER

Designed cardiac physical therapy program without virtual reality glasses

Designed cardiac physical therapy program ( study group )

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National heart institute

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at Department of Pediatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 2, 2024
• Study Start: August 10, 2024
• Primary Completion: January 10, 2025
• Study Completion: March 10, 2025
• Last Updated: May 22, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)