MedTrace Logo

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

NCT07729020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-07-27

No results posted yet for this study

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

Interventions

DEVICE

Immersive Virtual Reality Distraction

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.

OTHER

Standard Postoperative Dressing Care

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.

Sponsors & Collaborators

  • Istituto Giannina Gaslini

    collaborator OTHER

  • Gianluca Catania

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729020 on ClinicalTrials.gov