Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy

Servei Central d' Anestesiologia

Status: Completed

Conditions: Anxiety; Virtual Reality

Treatments: Device: Virtual Reality Educational Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03578393

IRV-2017-01

Details and patient eligibility

About

This study evaluate the effectiveness of the Virtual Reality Educational Program (RVEP) in the Paediatric Surgical Prehabilitation Unit to reduce the perioperative anxiety in children who undergo to elective surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.

Full description

During preoperative time, anxiety is one of the most frequent problems in children, causing an important health problem as long with pain. In the surgical fields there are two especially stressful moments for the child, the first one is the parent´s separation, and the second is the anaesthetic induction, which in up to 42% of cases can be traumatic.

Methods to treat paediatric anxiety have evolved in the last decades. Pharmacological therapy is one of the most used methods to treat anxiety in the immediate preoperative period, but complications and unwanted side effects are described. Due to this side effects, this study will evaluate the the effectiveness of the Virtual Reality Educational Program (RVEP) to reduce the perioperative anxiety in children.

Enrollment: 241 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children between 3 and 12 years old.
• Elective surgical intervention.
• ASA I-II (classification of the American Society of Anesthesiologists).
• Surgical complexity grade I-II according to National Institute for Clinical Excellence of the NHS.
• General anesthesia.
• Spanish or Catalan speaking families.
• Understanding the study and signing the informed consent of the study by parents or legal guardians.

Exclusion criteria

• Patients suffering from psychiatric or mental illness, psychomotor retardation, blindness or deafness.
• Denial of parents / legal guardians and / or children.
• Ambulatory surgery.
• Surgical intervention of the child the year before the current one.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 2 patient groups

Intervention

Experimental group

Description:

Will visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety.

Treatment:

Device: Virtual Reality Educational Program

Usual treatment

No Intervention group

Description:

Will be applied the usual treatment (provide information on the anaesthetic-surgical process).