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NCT07729020

Overview

NCT ID: NCT07729020
Lead Sponsor: Gianluca CataniaOTHER
Official Title: Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients: A Randomized Controlled Trial
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

Status and Timeline

Status: Completed
Last Update Posted: Jul 27, 2026Actual
Start Date: Sep 1, 2020Actual
Primary Completion Date: Dec 31, 2025Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria

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.

Assent obtained from the participant, when appropriate. Exclusion Criteria

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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 48Actual
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Dipartimento di scienze della salute, DISSAL - UNIGE

Similar Studies

Participant Group/Arms

Immersive Virtual Reality Plus Standard CareExperimental

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 AloneActive 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