Child, OnlyNCT06882382
Use of Virtual Reality in Children Undergoing Surgery
A study testing conventional physiotherapy and Virtual reality in people with Child, Only, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Aim: Early mobilization and exercise after surgery are very important to reduce the impact on lung function. The aim of this study was to compare the effects of early mobilization with virtual reality and conservative physiotherapy methods on pulmonary function, dyspnea, exercise capacity, pain, and kinesiophobia in… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Child, Only
- What is being tested?
- conventional physiotherapy and Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Jan 2024
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Children have visual and auditory sensory problems who required immobilization after surgery and had a chronic disease that would affect pulmonary function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Early Mobilization With Virtual Reality on Postoperative Respiratory Function, Exercise Capacity, and Pain in Children: A Randomized Controlled Trial
Aim: Early mobilization and exercise after surgery are very important to reduce the impact on lung function. The aim of this study was to compare the effects of early mobilization with virtual reality and conservative physiotherapy methods on pulmonary function, dyspnea, exercise capacity, pain, and kinesiophobia in children undergoing surgery.
Methods: The study included 27 children aged 5-18 years who underwent surgery. Among the children randomly divided into two groups, the control group (n = 14) received physiotherapy for 40 min twice a day for 3 days in the hospital after surgery, and the children were mobilized in and out of bed. In the virtual reality group (n = 13), in addition to physiotherapy practices, children were allowed to play virtual reality games for 20 min twice a day. Respiratory function, exercise capacity, and pain assessment were performed before surgery and before discharge.
Read the detailed description
Aim: Early mobilization and exercise after surgery are very important to reduce the impact on lung function. The aim of this study was to compare the effects of early mobilization with virtual reality and conservative physiotherapy methods on pulmonary function, dyspnea, exercise capacity, pain, and kinesiophobia in children undergoing surgery.
Methods: The study included 27 children aged 5-18 years who underwent surgery. Among the children randomly divided into two groups, the control group (n = 14) received physiotherapy for 40 min twice a day for 3 days in the hospital after surgery, and the children were mobilized in and out of bed. In the virtual reality group (n = 13), in addition to physiotherapy practices, children were allowed to play virtual reality games for 20 min twice a day. Respiratory function, exercise capacity, and pain assessment were performed before surgery and before discharge.
- Conditions
- Child, Only
- Being tested
- conventional physiotherapy, Virtual reality
- Keywords
- child, General Surgery, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physiotherapyOther
normal joint movements, chest physiotherapy, and mobilization for 40 min
Virtual realityOther
normal joint movements, chest physiotherapy, and mobilization for 40 min and 20 min virtual reality
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | Only conventional physiotherapy was applied to this group, including normal joint movements, chest physiotherapy, and mobilization for 40 min each, Receives: Other: conventional physiotherapy |
| virtual reality group | Experimental | The CG received conventional physiotherapy, including normal joint movements, chest physiotherapy, and mobilization for 40 min each, whereas the other group received 20 min of VR application every day in addition to conventional physiotherapy interventions. Receives: Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), ratio of forced expiratory volume in the first second to FVC (FEV1/FVC), peak expiratory flow rate (PEF), and forced mid-expiratory flow rate (FEF 25-75%)
The pulmonary function test was measured using a portable spirometer. According to American Torasic Society/European Respiratory Society (ATS/ERS) criteria, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), ratio of forced expiratory volume in the first second to FVC (FEV1/FVC), peak expiratory flow rate (PEF), and forced mid-expiratory flow rate (FEF 25-75%) were measured. The test was performed in the sitting position. The best of at least three technically acceptable manoeuvres with 95% agreement with each other was selected for statistical analysis.
Measured: 4 days
Secondary outcomes (8)
Respiratory muscle strength Assessment
Respiratory muscle strength was evaluated using an intraoral pressure measuring device. Maximal inspiratory pressure (MIP), inspiratory muscle strength, maximal expiratory pressure (MEP), and expiratory muscle strength were evaluated. MIP was measured using the intraoral pressure measurement method by performing rapid and deep inspiration in the residual volume after maximal expiration. MEP was recorded by performing rapid and deep expiration at total lung capacity after maximum inspiration. Children were verbally encouraged to record the best performance
Measured: 4 days
Modified Borg Scale
Dyspnea evaluation was performed via the Modified Borg Scale (MBS). The scale, which was developed to measure the effort expended during physical exercise, consists of 10 items describing the severity of dyspnea according to its degree. According to the scale, it shows that the severity of dyspnea increases from 0 to 10
Measured: 4 days
The 1-min step
The 1-min step (1-ST) test was performed. In the 1-ST, children were instructed to step reciprocally up and down a 6-in-high step for 1 min, and the number of steps taken was recorded.
Measured: 4 days
Timed Up and Go Test
Participants were evaluated using the Timed Up and Go Test (TUG). The TUG is a clinical test that measures various components, including walking speed, postural control, functional mobility, and balance. The child was asked to get up from a chair without armrests, return to a sign 3 m away, and sit down. The duration was recorded in seconds
Measured: 4 days
Numerical Pain Scale
The Numerical Pain Scale was used for pain assessment. The numerical pain scale assesses numerical values between 0 and 10 points
Measured: 4 days
Kinesiophobia
The Tampa Scale of Kinesiophobia was used to assess kinesiophobia. The scale consists of 17 questions questioning the person's fear of movement and is calculated on a total score between 17 and 68. A high score on the scale indicates a high level of kinesiophobia
Measured: 4 days
BMI
Height was measured and recorded in meters. Body weight was measured and recorded in kilograms. BMI was calculated by dividing body weight by height squared.
Measured: measured once, independent of time
10 MWT test
In the 10 MWT, children walked at a normal walking speed within a 10-m section of a 14-m walking distance to prevent the effect of acceleration and deceleration phases of walking, and the time was recorded in seconds
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Oct 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- One group received virtual reality and physiotherapy, while the other group received only physiotherapy
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabiha Bezgin, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882382
- Sponsor's protocol ID
- MKU-SB-1
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bezgin S, Huzmeli I, Katayifci N, Yildirim BA, Atici A. Use of virtual reality in children undergoing surgery. Front Pediatr. 2025 Jul 16;13:1633310. doi: 10.3389/fped.2025.1633310. eCollection 2025.
PubMed 40740824
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Mobilization With Virtual Reality on Postoperative Respiratory Function, Exercise Capacity, and Pain in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06882382
- Acronym / sponsor ID
- MKU-SB-1
- Conditions
- Child, Only
- Keywords
- child, General Surgery, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 18 Mar 2025 (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.
Aim: Early mobilization and exercise after surgery are very important to reduce the impact on lung function. The aim of this study was to compare the effects of early mobilization with virtual reality and conservative physiotherapy methods on pulmonary function, dyspnea, exercise capacity, pain, and kinesiophobia in children undergoing surgery.
Methods: The study included 27 children aged 5-18 years who underwent surgery. Among the children randomly divided into two groups, the control group (n = 14) received physiotherapy for 40 min twice a day for 3 days in the hospital after surgery, and the children were mobilized in and out of bed. In the virtual reality group (n = 13), in addition to physiotherapy practices, children were allowed to play virtual reality games for 20 min twice a day. Respiratory function, exercise capacity, and pain assessment were performed before surgery and before discharge.
Detailed description
Aim: Early mobilization and exercise after surgery are very important to reduce the impact on lung function. The aim of this study was to compare the effects of early mobilization with virtual reality and conservative physiotherapy methods on pulmonary function, dyspnea, exercise capacity, pain, and kinesiophobia in children undergoing surgery.
Methods: The study included 27 children aged 5-18 years who underwent surgery. Among the children randomly divided into two groups, the control group (n = 14) received physiotherapy for 40 min twice a day for 3 days in the hospital after surgery, and the children were mobilized in and out of bed. In the virtual reality group (n = 13), in addition to physiotherapy practices, children were allowed to play virtual reality games for 20 min twice a day. Respiratory function, exercise capacity, and pain assessment were performed before surgery and before discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group received virtual reality and physiotherapy, while the other group received only physiotherapy
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: conventional physiotherapyOnly conventional physiotherapy was applied to this group, including normal joint movements, chest physiotherapy, and mobilization for 40 min each, |
| virtual reality group | Experimental | Other: Virtual realityThe CG received conventional physiotherapy, including normal joint movements, chest physiotherapy, and mobilization for 40 min each, whereas the other group received 20 min of VR application every day in addition to conventional physiotherapy interventions. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Children have visual and auditory sensory problems who required immobilization after surgery and had a chronic disease that would affect pulmonary function
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 |
|---|---|---|
| conventional physiotherapynormal joint movements, chest physiotherapy, and mobilization for 40 min | Other | control group |
| Virtual realitynormal joint movements, chest physiotherapy, and mobilization for 40 min and 20 min virtual reality | Other | virtual reality group |
Primary outcome
forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), ratio of forced expiratory volume in the first second to FVC (FEV1/FVC), peak expiratory flow rate (PEF), and forced mid-expiratory flow rate (FEF 25-75%)
Time frame: 4 days
The pulmonary function test was measured using a portable spirometer. According to American Torasic Society/European Respiratory Society (ATS/ERS) criteria, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), ratio of forced expiratory volume in the first second to FVC (FEV1/FVC), peak expiratory flow rate (PEF), and forced mid-expiratory flow rate (FEF 25-75%) were measured. The test was performed in the sitting position. The best of at least three technically acceptable manoeuvres with 95% agreement with each other was selected for statistical analysis.
8 secondary outcomes
Respiratory muscle strength Assessment
Time frame: 4 days
Modified Borg Scale
Time frame: 4 days
The 1-min step
Time frame: 4 days
Timed Up and Go Test
Time frame: 4 days
Numerical Pain Scale
Time frame: 4 days
Kinesiophobia
Time frame: 4 days
BMI
Time frame: measured once, independent of time
10 MWT test
Time frame: 4 days
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 18 Mar 2025.
- Derived from this study: PubMed 40740824Bezgin S, Huzmeli I, Katayifci N, Yildirim BA, Atici A. Use of virtual reality in children undergoing surgery. Front Pediatr. 2025 Jul 16;13:1633310. doi: 10.3389/fped.2025.1633310. eCollection 2025.
- Individual participant dataSharing planned: No
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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 conventional physiotherapy and Virtual reality in people with Child, Only, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
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 0 inclusion and 1 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 18 Mar 2025. 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 Turkey (Türkiye). 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?
forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), ratio of forced expiratory volume in the first second to FVC (FEV1/FVC), peak expiratory flow rate (PEF), and forced mid-expiratory flow rate (FEF 25-75%) (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06882382, which also lists 1 linked publication.
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 18 Mar 2025.