Preoperative AnxietyVIRTUALPEDNCT04043663
Effects of Virtual Reality on Perioperative Pediatric Anxiety
A study testing Virtual Reality glasses and standard perioperative care without virtual reality program in people with Preoperative Anxiety and Maladaptive Postoperative Behavior, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety, Maladaptive Postoperative Behavior, Emergence Delirium
- What is being tested?
- Virtual Reality glasses and standard perioperative care without virtual reality program
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2019to 15 Jul 2021
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child between 4 and 12 years old
- Elective ambulatory surgery
- Parents posses a smart phone
- Child and parents understand Spanish or Catalan
- Patient information has been explained
- Informed Consent is signed
- Surgery scheduled in the morning
Who cannot join
- Child has hearing impairment
- Child has visual impairment
- Child has previous experience of anesthesia
- American Society os Anesthesiologists (ASA) score of III or greater
- Children with history of seizures
- Children under psychiatric treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Teresa Franco
Badalona, Barcelona, 08916
Teresa Franco, MD, +34934978904 ext. 8904, tfranco.germanstrias@gencat.cat
Alicia Melero, MD
About this study
This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program.
Read the detailed description
It is well known that there is a high incidence of significant anxiety in pediatric population perioperatively, with adverse side effects in terms of emergence delirium and maladaptive postoperative behaviors. Many different strategies have been designed in order to minimize these negative consequences.
Virtual reality is a new and simple technology that can be used at young ages. The aim of this study is to measure anxiety levels at different times in children scheduled for ambulatory surgery compared to patients with standard care without virtual reality.
- Being tested
- Virtual Reality glasses, standard perioperative care without virtual reality program
- Keywords
- virtual reality, pediatric surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality glassesDevice
Children are encouraged to watch the virtual reality program at least 24 hours before surgery.
standard perioperative care without virtual reality programProcedure or surgery
standard perioperative care without virtual reality program
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality program group | Experimental | Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery. Receives: Device: Virtual Reality glasses |
| control group | Active comparator | standard perioperative care without virtual reality program Receives: Procedure: standard perioperative care without virtual reality program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Anxiety level
In children: measured using the modified Yale Perioperative Anxiety Scale, blinded reported by a trained nurse before the patient is transferred to the operating room. Rage from 23.5 up to 100, deemed high anxiety level if test rated over 30
Measured: baseline to 1 day
Secondary outcomes (1)
Salivary Cortisol level
In children: Saliva sample collection using Salivette system before the patient is transferred to the operating room. Levels over 8nmol/l can be caused by high anxiety level
Measured: baseline to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start15 Jul 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Franco, Germans Trias i Pujol Hospital
- Investigators
- Teresa Franco, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043663
- Sponsor's protocol ID
- VIRTUALPED
- Acronym
- VIRTUALPED
- Status last verified
- Aug 2019
- First submitted
- 25 Jul 2019
- Last updated
- 5 Aug 2019
- 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 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality on Perioperative Pediatric Anxiety
- ClinicalTrials.gov ID
- NCT04043663
- Acronym / sponsor ID
- VIRTUALPED / VIRTUALPED
- Keywords
- virtual reality, pediatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 2 Aug 2019 (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.
This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program.
Detailed description
It is well known that there is a high incidence of significant anxiety in pediatric population perioperatively, with adverse side effects in terms of emergence delirium and maladaptive postoperative behaviors. Many different strategies have been designed in order to minimize these negative consequences.
Virtual reality is a new and simple technology that can be used at young ages. The aim of this study is to measure anxiety levels at different times in children scheduled for ambulatory surgery compared to patients with standard care without virtual reality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Virtual reality program group | Experimental | Device: Virtual Reality glassesVirtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery. |
| control group | Active comparator | Procedure: standard perioperative care without virtual reality programstandard perioperative care without virtual reality program |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child between 4 and 12 years old
- Elective ambulatory surgery
- Parents posses a smart phone
- Child and parents understand Spanish or Catalan
- Patient information has been explained
Key exclusion criteria (6 listed)
- Child has hearing impairment
- Child has visual impairment
- Child has previous experience of anesthesia
- American Society os Anesthesiologists (ASA) score of III or greater
- Children with history of seizures
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 glassesChildren are encouraged to watch the virtual reality program at least 24 hours before surgery. | Device | Virtual reality program group |
| standard perioperative care without virtual reality programstandard perioperative care without virtual reality program | Procedure or surgery | control group |
Primary outcome
Perioperative Anxiety level
Time frame: baseline to 1 day
In children: measured using the modified Yale Perioperative Anxiety Scale, blinded reported by a trained nurse before the patient is transferred to the operating room. Rage from 23.5 up to 100, deemed high anxiety level if test rated over 30
1 secondary outcome
Salivary Cortisol level
Time frame: baseline to 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- 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.
Teresa Franco principal investigator
Germans Trias i Pujol Hospital
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 glasses and standard perioperative care without virtual reality program in people with Preoperative Anxiety and Maladaptive Postoperative Behavior, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Aug 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Franco, MD (+34934978904 ext. 8904, tfranco.germanstrias@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Anxiety level (time frame: baseline to 1 day). 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 5 Aug 2019.