Children After Open Heart SurgeryNCT06712368
Effect of Virtual Reality on Pain, Arterial Blood Gases and Functional Capacity in Children After Open Heart Surgery
A study testing virtual reality glasses and Designed cardiac physical therapy program in people with Children After Open Heart Surgery, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Children After Open Heart Surgery
- What is being tested?
- virtual reality glasses and Designed cardiac physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2024to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both genders will be included.
- Their age range from 6 to 12 years.
- Children after open heart surgery ( phase I cardiac rehabilitation).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- virtual reality glasses, Designed cardiac physical therapy program
- Keywords
- virtual reality, heart surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesDevice
Also called Experimental: study group
Designed cardiac physical therapy program applied through virtual reality glasses for study group
Designed cardiac physical therapy programOther
Designed cardiac physical therapy program without virtual reality glasses
| Study group | Role | What they receive |
|---|---|---|
| Designed cardiac physical therapy program ( study group ) | Active comparator | Designed cardiac physical therapy program Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level
Pain level assessment by Wong-Baker faces scale:
Measured: 1 hour /session 1 time / day for 5 consecutive days
arterial blood gases
Arterial Blood Gases Analysis to detect blood gases
Measured: 1 hour /session 1 time / day for 5 consecutive days
functional capacity
The Six-Minute Walk Test (6MWT) for assessment functional capacity
Measured: 1 hour /session 1 time / day for 5 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start10 Aug 2024
- Primary completion10 Jan 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children After Open Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mamdouh Abdelmoaty Abdelaal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712368
- Sponsor's protocol ID
- P.T.REC/012/005353
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Pain, Arterial Blood Gases and Functional Capacity in Children After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT06712368
- Acronym / sponsor ID
- P.T.REC/012/005353
- Conditions
- Children After Open Heart Surgery
- Keywords
- virtual reality, heart surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Designed cardiac physical therapy program ( study group ) | Active comparator | Other: Designed cardiac physical therapy programDesigned 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Both genders will be included.
- Their age range from 6 to 12 years.
- Children after open heart surgery ( phase I cardiac rehabilitation).
Key exclusion criteria (7 listed)
- Any child Suffering from any other chronic congenital diseases.
- Severe visual or auditory problems.
- Neurological problems.
- Vertigo problems.
- Post surgical hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality glassesAlso: Experimental: study groupDesigned cardiac physical therapy program applied through virtual reality glasses for study group | Device | – |
| Designed cardiac physical therapy programDesigned cardiac physical therapy program without virtual reality glasses | Other | Designed cardiac physical therapy program ( study group ) |
Primary outcome
pain level
Time frame: 1 hour /session 1 time / day for 5 consecutive days
Pain level assessment by Wong-Baker faces scale:
arterial blood gases
Time frame: 1 hour /session 1 time / day for 5 consecutive days
Arterial Blood Gases Analysis to detect blood gases
functional capacity
Time frame: 1 hour /session 1 time / day for 5 consecutive days
The Six-Minute Walk Test (6MWT) for assessment functional capacity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses and Designed cardiac physical therapy program in people with Children After Open Heart Surgery, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level (time frame: 1 hour /session 1 time / day for 5 consecutive days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.