- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06882382
Use of Virtual Reality in Children Undergoing Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hatay, Turkey, 31010
- Sabiha Bezgin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria Between the ages of 5 and 18 undergone surgery for inguinal hernia, undescended testicle, hydrocele, cord cyst, umbilical hernia, circumcision, and distal hypospadias
Exclusion criteria
Children have visual and auditory sensory problems who required immobilization after surgery and had a chronic disease that would affect pulmonary function
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: control group
Only conventional physiotherapy was applied to this group, including normal joint movements, chest physiotherapy, and mobilization for 40 min each,
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normal joint movements, chest physiotherapy, and mobilization for 40 min
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Experimental: virtual reality group
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.
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normal joint movements, chest physiotherapy, and mobilization for 40 min and 20 min virtual reality
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory muscle strength Assessment
Time Frame: 4 days
|
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
|
4 days
|
|
Modified Borg Scale
Time Frame: 4 days
|
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
|
4 days
|
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The 1-min step
Time Frame: 4 days
|
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.
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4 days
|
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Timed Up and Go Test
Time Frame: 4 days
|
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
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4 days
|
|
Numerical Pain Scale
Time Frame: 4 days
|
The Numerical Pain Scale was used for pain assessment.
The numerical pain scale assesses numerical values between 0 and 10 points
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4 days
|
|
Kinesiophobia
Time Frame: 4 days
|
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
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4 days
|
|
BMI
Time Frame: measured once, independent of time
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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.
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measured once, independent of time
|
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10 MWT test
Time Frame: 4 days
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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
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4 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MKU-SB-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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