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Completed

NCT Number: NCT06882382

Use of Virtual Reality in Children Undergoing Surgery

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.

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Key information

Conditions

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sabiha Bezgin

Hatay, 31010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Physiotherapy

Other

normal joint movements, chest physiotherapy, and mobilization for 40 min

Virtual Reality

Other

normal joint movements, chest physiotherapy, and mobilization for 40 min and 20 min virtual reality

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. BMI

    Time frame: measured once, independent of time

    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.

  8. 10 MWT test

    Time frame: 4 days

    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

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Official study title

Effects of Early Mobilization With Virtual Reality on Postoperative Respiratory Function, Exercise Capacity, and Pain in Children: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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