AnxietyNCT06862830
The Effectiveness of Virtual Reality in the Management of Procedural Anxiety and Pain in Children Suffering From Chronic Pathologies or Burn Injuries.
A study testing Virtual reality video in people with Anxiety and Chronic Disease, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial summary
Single-center, randomized, controlled clinical trial (RCT) to evaluate the efficacy of VR on pain and anxiety in children with chronic diseases undergoing painful procedures in an outpatient or day hospital setting Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Anxiety, Chronic Disease, Pain
- What is being tested?
- Virtual reality video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- 22 Oct 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Eligibility Criteria: Inclusion
The study population includes children who meet the following criteria:
- Diagnosis of a chronic condition, aged 3 to 18 years, without visual impairments or cognitive deficits, and with a confirmed diagnosis of the condition.
- Children receiving care in the wound care nursing clinic or Medical Day Hospital (DH) who require minimally invasive painful procedures.
- Assent and informed consent provided by both the children and their parents.
- Children with chronic conditions that do not inherently cause chronic pain, which could alter pain perception (e.g., rheumatoid arthritis, diabetic foot, muscular dystrophy).
- Children able to understand and communicate in Italian or English.
- Parents able to understand and communicate in Italian or English. Eligibility Criteria: Exclusion
Children with the following characteristics will be excluded from the study:
- Chronic condition not yet diagnosed.
- Use of eyeglasses, presence of amblyopia or monocular vision.
- Chronic pain, which could distort pain perception during the procedure.
- Use of analgesic therapy within the last 8 hours, which could bias data collection results (the only prohibited therapy in the study and a reason for exclusion).
- Cognitive impairment preventing the proper use of assessment scales.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Virtual Reality in the Management of Procedural Anxiety and Pain in Children Suffering From Chronic Pathologies or Burn Injuries. Single-center Randomized Controlled Trial.
Single-center, randomized, controlled clinical trial (RCT) to evaluate the efficacy of VR on pain and anxiety in children with chronic diseases undergoing painful procedures in an outpatient or day hospital setting
- Conditions
- Anxiety, Chronic Disease, Pain
- Being tested
- Virtual reality video
- Keywords
- Virtual Reality, Chronic pain, Paediatric, Chronic disease
- Medical subject headings
- Anxiety Disorders, Chronic Disease, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality videoOther
Virtual reality video: luna park, carousels, space, zoo, safari, dinosaurs, sightseeing, role-play
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality video | Experimental | Not described Receives: Other: Virtual reality video |
| Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in anxiety score
Effectiveness of VR in reducing pain and anxiety in children undergoing painful procedures (blood draw, intramuscular injection, and wound dressing).
Measured: From recruitment to end of painful procedure
Percentage reduction in pain
Measured: From recruitment to end of painful procedure
Secondary outcomes (1)
Percentage of reduction in parental anxiety
Measured: From recruitment to end of painful procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start22 Oct 2024
- Primary completion30 Dec 2024
- Study completionApr 2025 (estimated)
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.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biagio Nicolosi, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862830
- Sponsor's protocol ID
- RV-PLS
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Nel presente studio, verranno condivisi i seguenti dati individuali dei pazienti (IPD) in forma anonimizzata e aggregata, garantendo il rispetto delle normative sulla privacy e sulla protezione dei dati personali: 1. Dati Demografici e Clinici * Età del partecipante (fasce di età) * Genere * Patologia cronica principale * Eventuali comorbidità * Tipo di famiglia (monogenitoriale, entrambi i genitori, altro) 2. Dati sulla Procedura e sull'Intervento * Tipo di procedura dolorosa eseguita (prelievo ematico, iniezione intramuscolare, medicazione) * Assegnazione del paziente al gruppo sperimentale (RV) o di controllo (cure standard) 3. Dati sulla Valutazione dell'Ansia e del Dolore * Punteggi pre-procedurali di ansia anticipatoria valutati con: * M-YPAS (3-6 anni) * CAPS (6-17 anni e genitori) * Punteggi post-procedurali del dolore valutati con: * Wong-Baker Faces Scale (3-8 anni) * Numerical Rating Scale (NRS) (8-17 anni) 4. Dati Statistici e di Outcome * Differenze nei p
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Virtual Reality in the Management of Procedural Anxiety and Pain in Children Suffering From Chronic Pathologies or Burn Injuries. Single-center Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06862830
- Acronym / sponsor ID
- RV-PLS
- Conditions
- Anxiety, Chronic Disease, Pain
- Keywords
- Virtual Reality, Chronic pain, Paediatric, Chronic disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 6 Mar 2025 (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.
Single-center, randomized, controlled clinical trial (RCT) to evaluate the efficacy of VR on pain and anxiety in children with chronic diseases undergoing painful procedures in an outpatient or day hospital setting
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality video | Experimental | Other: Virtual reality video |
| Standard of care | No intervention | – |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Virtual reality videoVirtual reality video: luna park, carousels, space, zoo, safari, dinosaurs, sightseeing, role-play | Other | Virtual reality video |
Primary outcome
Percentage reduction in anxiety score
Time frame: From recruitment to end of painful procedure
Effectiveness of VR in reducing pain and anxiety in children undergoing painful procedures (blood draw, intramuscular injection, and wound dressing).
Percentage reduction in pain
Time frame: From recruitment to end of painful procedure
1 secondary outcome
Percentage of reduction in parental anxiety
Time frame: From recruitment to end of painful procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Yes. Nel presente studio, verranno condivisi i seguenti dati individuali dei pazienti (IPD) in forma anonimizzata e aggregata, garantendo il rispetto delle normative sulla privacy e sulla protezione dei dati personali: 1. Dati Demografici e Clinici * Età del partecipante (fasce di età) * Genere * Patologia cronica principale * Eventuali comorbidità * Tipo di famiglia (monogenitoriale, entrambi i genitori, altro) 2. Dati sulla Procedura e sull'Intervento * Tipo di procedura dolorosa eseguita (prelievo ematico, iniezione intramuscolare, medicazione) * Assegnazione del paziente al gruppo sperimentale (RV) o di controllo (cure standard) 3. Dati sulla Valutazione dell'Ansia e del Dolore * Punteggi pre-procedurali di ansia anticipatoria valutati con: * M-YPAS (3-6 anni) * CAPS (6-17 anni e genitori) * Punteggi post-procedurali del dolore valutati con: * Wong-Baker Faces Scale (3-8 anni) * Numerical Rating Scale (NRS) (8-17 anni) 4. Dati Statistici e di Outcome * Differenze nei p
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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 Virtual reality video in people with Anxiety and Chronic Disease, run by Meyer Children's Hospital IRCCS 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?
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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage reduction in anxiety score (time frame: From recruitment to end of painful procedure). The study lists 2 primary outcomes in all. 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 6 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.