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Clinical Trial NCT06604364 (RAGAZ) for Virtual Reality is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery (RAGAZ) 50 Pediatric Virtual

Recruiting
Clinical Trial NCT06604364 (RAGAZ) is an interventional study for Virtual Reality that is recruiting. It started on 3 June 2024 with plans to enroll 50 participants. Led by Istituto Ortopedico Rizzoli, it is expected to complete by 3 June 2026. The latest data from ClinicalTrials.gov was last updated on 18 February 2026.
Brief Summary
This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to see if using virtual reality (VR) can help children feel less anxious and experience less pain during minor orthopedic surgeries. The research will compare the effects of VR to the usual pre-surgery sedative medication.

**Study Hypotheses**

The researchers hypothesize that using VR will:

1. ...

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Detailed Description
**Detailed Description**

This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to evaluate the effectiveness of virtual reality (VR) in reducing perioperative anxiety and pain in children undergoing minor orthopedic surgeries. The study will compare the use of VR headsets to the traditional method of pre-surgery sedation with medication.

**Purpose...

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Official Title

realtà Aumentata Generatrice di Ansia Zero

Conditions
Virtual Reality
Other Study IDs
  • RAGAZ
  • 211/2024/DISP/IOR
NCT ID Number
NCT06604364
Start Date (Actual)
2024-06-03
Last Update Posted
2026-02-18
Completion Date (Estimated)
2026-06-03
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No Interventioncontrol
pre-surgery sedation
N/A
ExperimentalVR
virtual reality sedation
hypno VR
pre-surgery sedation using virtual reality headset
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
anxiety level
level of anxiety with cam-s
24 hours
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
hormons levels
levels of stress hormons
preoperative
pain level
difference in pain levels
24 hours
compliance during induction
compliance during induction of anesthesia with micc
during induction
drugs dosage
dosage of drugs necessary for induction of anesthesia
intraoperative
surgeons satisfaction
general satisfaction of the surgeons from 1 to 10
immediately after the intervention
parents satisfaction
general satisfaction of the parents from 1 to 10
immediately after the intervention
or time occupation
time of occupation of the or
intraoperative
adverse event
adverse avent using virtual reality
24 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
7 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Children aged 7 to 12 years.
  • Scheduled for minor orthopedic surgery with a duration of less than 60 minutes.
  • Eligible for regional anesthesia.
  • Able to understand and cooperate with the study procedures.
  • Consent from both the child and their parent or legal guardian.

  • Facial trauma that prevents the use of VR headsets.
  • Blindness or significant visual impairment.
  • Deafness or significant hearing impairment.
  • Cognitive impairments or intellectual disabilities.
  • Inability to understand the language used in the VR content.
  • Poor fit of the VR headset on the child's face.
  • Inability to understand Italian.
  • Current use of analgesics or sedatives at home.
  • Certified psychiatric diagnosis.
  • Epilepsy or history of seizures.
  • Recent head trauma, severe headaches, or vertigo.
  • Any condition deemed by the anesthesiologist to be unsafe for VR use.
  • Failure to properly apply topical anesthetics before invasive procedures.
  • Allergy to local anesthetics.
  • Surgery duration expected to exceed 60 minutes.
  • Anticipated need for general anesthesia or deep sedation requiring advanced airway management.
  • Predicted difficult venous access (DIVA)
Istituto Ortopedico Rizzoli logoIstituto Ortopedico Rizzoli
No contact data.
1 Study Locations in 1 Countries
Istituto Ortopedico Rizzoli, Bologna, Italy
vittorio ferrari, Contact, 051636842, [email protected]
Lesley de Pietri, Principal Investigator
Recruiting