NCT06882382

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

March 6, 2025

Last Update Submit

March 12, 2025

Conditions

Child, Only

Keywords

childGeneral Surgeryvirtual reality

Outcome Measures

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%)

    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

Secondary Outcomes (8)

  • Respiratory muscle strength Assessment

    4 days

  • Modified Borg Scale

    4 days

  • The 1-min step

    4 days

  • Timed Up and Go Test

    4 days

  • Numerical Pain Scale

    4 days

  • +3 more secondary outcomes

Study Arms (2)

control group

EXPERIMENTAL

Only conventional physiotherapy was applied to this group, including normal joint movements, chest physiotherapy, and mobilization for 40 min each,

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.

Other: Virtual reality

Interventions

conventional physiotherapyOTHER

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

control group
Virtual realityOTHER

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

virtual reality group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Children have visual and auditory sensory problems who required immobilization after surgery and had a chronic disease that would affect pulmonary function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sabiha Bezgin

Hatay, 31010, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 40740824DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group received virtual reality and physiotherapy, while the other group received only physiotherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mustafa Kemal University

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 18, 2025

Study Start

October 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)