AnxietyVR OrthoPedNCT07729020
Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients
A study testing Immersive Virtual Reality Distraction and Standard Postoperative Dressing Care in people with Anxiety and Pain, run by Gianluca Catania at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Anxiety, Pain, Post Operative
- What is being tested?
- Immersive Virtual Reality Distraction and Standard Postoperative Dressing Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di scienze della salute, DISSAL - UNIGE
Genoa, Liguria, 16132
About this study
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
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?
Read more
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
Read the detailed description
Postoperative orthopedic dressing changes can cause anxiety, pain, and physiological distress in pediatric patients. Immersive virtual reality may provide a non-pharmacological form of distraction by directing the participant's attention away from the clinical procedure and toward an engaging virtual environment.
This randomized clinical trial was conducted in a pediatric orthopedic unit to evaluate the use of immersive virtual reality during postoperative dressing changes. After enrollment and baseline assessment, participants were randomly assigned to receive either immersive virtual reality in addition to the usual dressing procedure or standard care alone.
Participants assigned to the virtual reality group wore a head-mounted display and viewed an immersive virtual environment during the dressing change. Participants assigned to the standard care group underwent the same clinical procedure according to usual practice without virtual reality. The dressing change was performed by the clinical team in accordance with routine postoperative care.
Anxiety, pain, heart rate, respiratory rate and peripheral oxygen saturation were assessed at predefined time points before, during, and after the procedure, as applicable. These measurements were used to examine whether immersive virtual reality was associated with reduced psychological and physiological distress during the dressing change.
The study was designed to provide evidence on the potential usefulness of immersive virtual reality as a non-drug supportive intervention during postoperative procedures in pediatric orthopedic care.
- Conditions
- Anxiety, Pain, Post Operative
- Being tested
- Immersive Virtual Reality Distraction, Standard Postoperative Dressing Care
- Keywords
- virtual reality, pediatric patients, orthopedic surgery
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality DistractionDevice
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.
Standard Postoperative Dressing CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Postoperative Dressing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before and immediately after the first postoperative orthopedic dressing procedure
Secondary outcomes (2)
Change in Pain Intensity Assessed Using the Faces Pain Scale
Pain intensity in participants aged 6 to 10 years was assessed immediately before and immediately after the first postoperative orthopedic dressing procedure using the Faces Pain Scale. Higher scores indicate greater pain intensity. Change in pain was calculated as the post-procedure score minus the pre-procedure score.
Measured: Immediately before and immediately after the first postoperative orthopedic dressing procedure
Change in Pain Intensity Assessed Using the Numeric Rating Scale
Pain intensity in participants older than 10 years was assessed immediately before and immediately after the first postoperative orthopedic dressing procedure using the Numeric Rating Scale (0-10). Higher scores indicate greater pain intensity. Change in pain was calculated as the post-procedure score minus the pre-procedure score.
Measured: Immediately before and immediately after the first postoperative orthopedic dressing procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Sep 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gianluca Catania
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Giannina Gaslini
- Responsible party
- Sponsor-investigator, Gianluca Catania, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729020
- Sponsor's protocol ID
- VR OrthoPed
- Acronym
- VR OrthoPed
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07729020
- Acronym / sponsor ID
- VR OrthoPed / VR OrthoPed
- Conditions
- Anxiety, Pain, Post Operative
- Keywords
- virtual reality, pediatric patients, orthopedic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Gianluca CataniaUniversity, hospital or other
- Collaborators
- Istituto Giannina Gaslini
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Postoperative orthopedic dressing changes can cause anxiety, pain, and physiological distress in pediatric patients. Immersive virtual reality may provide a non-pharmacological form of distraction by directing the participant's attention away from the clinical procedure and toward an engaging virtual environment.
This randomized clinical trial was conducted in a pediatric orthopedic unit to evaluate the use of immersive virtual reality during postoperative dressing changes. After enrollment and baseline assessment, participants were randomly assigned to receive either immersive virtual reality in addition to the usual dressing procedure or standard care alone.
Participants assigned to the virtual reality group wore a head-mounted display and viewed an immersive virtual environment during the dressing change. Participants assigned to the standard care group underwent the same clinical procedure according to usual practice without virtual reality. The dressing change was performed by the clinical team in accordance with routine postoperative care.
Anxiety, pain, heart rate, respiratory rate and peripheral oxygen saturation were assessed at predefined time points before, during, and after the procedure, as applicable. These measurements were used to examine whether immersive virtual reality was associated with reduced psychological and physiological distress during the dressing change.
The study was designed to provide evidence on the potential usefulness of immersive virtual reality as a non-drug supportive intervention during postoperative procedures in pediatric orthopedic care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality Plus Standard Care | Experimental | Device: Immersive Virtual Reality DistractionParticipants 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. |
| Standard Care Alone | Active comparator | Other: Standard Postoperative Dressing CareParticipants 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality DistractionParticipants 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. | Device | Immersive Virtual Reality Plus Standard Care |
| Standard Postoperative Dressing CareParticipants 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. | Other | Standard Care Alone |
Primary outcome
Change in Anxiety Assessed Using the Visual Analogue Scale for Anxiety
Time frame: Immediately before and immediately after the first postoperative orthopedic dressing procedure
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.
2 secondary outcomes
Change in Pain Intensity Assessed Using the Faces Pain Scale
Time frame: Immediately before and immediately after the first postoperative orthopedic dressing procedure
Change in Pain Intensity Assessed Using the Numeric Rating Scale
Time frame: Immediately before and immediately after the first postoperative orthopedic dressing procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Distraction and Standard Postoperative Dressing Care in people with Anxiety and Pain, run by Gianluca Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Assessed Using the Visual Analogue Scale for Anxiety (time frame: Immediately before and immediately after the first postoperative orthopedic dressing procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.