Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients

NCT07729020 | Completed

• 1 other identifier: VR OrthoPed
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to learn whether immersive virtual reality can reduce anxiety and pain in children and adolescents undergoing postoperative orthopedic dressing changes. The main questions it aims to answer are: Does immersive virtual reality reduce anxiety during postoperative dressing changes compared with standard care? Does immersive virtual reality reduce pain and physiological signs of distress, such as changes in heart rate and respiratory rate? Researchers will compare participants who use an immersive virtual reality headset during the dressing change with participants who receive standard care without virtual reality. Participants will: Be randomly assigned to the virtual reality group or the standard care group Undergo a postoperative orthopedic dressing change with or without immersive virtual reality Report their anxiety and pain before and after the procedure Have their heart rate and respiratory rate measured before, during, and after the dressing change

Conditions

Pain; Post Operative; Anxiety

Keywords

virtual reality; pediatric patients; orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• Change in Anxiety Assessed Using the Visual Analogue Scale for Anxiety

  Anxiety was assessed using the Visual Analogue Scale for Anxiety (VAS-A), a 100 mm horizontal scale ranging from 0, indicating no anxiety, to 100, indicating maximum anxiety. Higher scores indicate greater anxiety. Change in anxiety was calculated as the score immediately after the procedure minus the score immediately before the procedure. A negative change score indicates a reduction in anxiety.

  Immediately before and immediately after the first postoperative orthopedic dressing procedure

Secondary Outcomes (2)

• Change in Pain Intensity Assessed Using the Faces Pain Scale

  Immediately before and immediately after the first postoperative orthopedic dressing procedure

• Change in Pain Intensity Assessed Using the Numeric Rating Scale

  Immediately before and immediately after the first postoperative orthopedic dressing procedure.

Study Arms (2)

Immersive Virtual Reality Plus Standard Care

EXPERIMENTAL

Participants received the first postoperative orthopedic dressing procedure according to routine clinical practice while using an immersive virtual reality headset. The headset displayed an immersive virtual environment throughout the dressing procedure as a non-pharmacological distraction intervention. Standard clinical monitoring and nursing care were provided.

Device: Immersive Virtual Reality Distraction

Standard Care Alone

ACTIVE COMPARATOR

Participants received the first postoperative orthopedic dressing procedure according to routine clinical practice without the use of immersive virtual reality. Standard clinical monitoring and nursing care were provided.

Other: Standard Postoperative Dressing Care

Interventions

Standard Postoperative Dressing Care OTHER

Participants underwent the first postoperative orthopedic dressing procedure according to routine clinical practice without the use of immersive virtual reality. Standard nursing care and clinical monitoring were provided throughout the procedure.

Standard Care Alone

Immersive Virtual Reality Distraction DEVICE

Participants used an immersive virtual reality headset during the first postoperative orthopedic dressing procedure. The headset presented an immersive virtual environment intended to divert attention from the clinical procedure and reduce anxiety, pain, and physiological stress. The virtual reality intervention was provided in addition to the routine postoperative dressing care delivered by the clinical team. The headset was worn during the dressing procedure and removed after its completion.

Immersive Virtual Reality Plus Standard Care

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 6-18 years.
• Undergoing corrective orthopedic surgery for congenital or acquired limb deformities, with or without external fixation devices, or spinal arthrodesis for scoliosis or spondylolisthesis.
• Undergoing the first postoperative wound dressing procedure.
• Written informed consent obtained from a parent or legal guardian.

You may not qualify if:

• Neurological disorders.
• History of epilepsy.
• Prematurity.
• Sensory impairments preventing the use of the virtual reality headset.
• Cognitive impairments preventing the use of the virtual reality headset.
• Motor limitations preventing the use of the virtual reality headset.

Sponsors & Collaborators

• Istituto Giannina Gaslini: collaborator
• Gianluca Catania: lead

Study Sites (1)

Dipartimento di scienze della salute, DISSAL - UNIGE

Genoa, Liguria, 16132, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 27, 2026
• Study Start: September 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)