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Trial record 57 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

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

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ClinicalTrials.gov Identifier: NCT03578393
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Adriana Carbó García, Servei Central d' Anestesiologia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Virtual Reality Device: Virtual Reality Educational Program Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy
Actual Study Start Date : February 2, 2019
Estimated Primary Completion Date : September 2, 2019
Estimated Study Completion Date : September 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Will visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety.
Device: Virtual Reality Educational Program
The study group, in addition to providing the usual information about the anaesthetic-surgical process, will visualize an educational video through virtual reality glasses, of a maximum duration of 5 minutes. The video's explanation will be adapted according to the age ranges. Once the video is finished, if there aren't doubts, the visit will be concluded.

No Intervention: Usual treatment
Will be applied the usual treatment (provide information on the anaesthetic-surgical process).



Primary Outcome Measures :
  1. Preoperative Change of Paediatric Anxiety level [ Time Frame: 3 days: 1.- On preanesthetic visit (7-10 days before surgery), using mYPAS scale. 2.- The surgery day, during parents separation, using mYPAS-SF. 3.- Postoperative day (24 hours after surgery), at hospitalization room, using a mYPAS scale. ]

    It will be measured by modified-Yale Preoperative Anxiety Scale (mYPAS) and its short form (mYPAS-SF).

    The mYPAS score range is: 23,3 to 100, majors scores indicate anxiety. It's considerate an anxiety cut-off point scores >40, and no anxiety <40. The mYPAS-SF score range is 22,7 to 100.



Secondary Outcome Measures :
  1. Paediatric pain [ Time Frame: 2 days. The surgery day and the postoperative day (24 hours after surgery). ]
    Measured by Faces Pain Rating Scale o Wong Baker Faces. It consist in 6 faces, The faces represent "no harm" to "worse damage" and the score goes from 0 to 10.

  2. Modified Aldrete postanesthetic recuperation [ Time Frame: 1 day. The surgery day ]
    It is a hetero-administered scale consisting of 10 items. Each item responds to a Likert scale of 0 to 2, with a total range ranging from 0 to 10. The cut-off point is at 80% of the maximum score, ie 18 points suggest adequate recovery after anesthesia.

  3. Parental satisfaction [ Time Frame: 1 day. At hospital discharge (24 hours after surgery). ]
    Numeric Scale indicate 0= unsatisfied and 10= totally satisfied.

  4. Resources [ Time Frame: 1 day. The surgery day. ]

    Will be measured using a self-created questionnaire. It contains variables as:

    • Anaesthesia induction times (in minutes)
    • Time between the surgery ends and recovery discharge (in minutes)
    • Surgery times (in minutes)

  5. Children's collaboration during anaesthesia induction. [ Time Frame: 1 day. The surgery day, during anaesthesia induction. ]
    It will be measured by Induction Compliance Checklist (ICC). ICC score range is 0 to 10, 0 means collaborate and 10 no collaborate.

  6. Paediatric Delirium [ Time Frame: 2 days. The surgery day and the postoperative day (24 hours after surgery). ]
    Paediatric Anesthesia Emergence Delirium (PAED). It consists of 5 items with 5 possible answers on a scale of 0 to 4, with a score of > 10 indicating postsurgical agitation.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • Surgery scheduled between 7 and 10 days after the preanesthetic visit.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578393


Contacts
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Contact: Adriana Carbó García, Nurse +34650073209 adriana_carbo87@hotmail.com
Contact: Adriana Carbó García, Nurse +932906005 adriana_carbo87@hotmail.com

Locations
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Spain
Centro Medico Teknon Recruiting
Barcelona, Spain, 08012
Contact: Adriana Carbó, Nurse    650073209    adriana_carbo87@hotmail.com   
Sponsors and Collaborators
Servei Central d' Anestesiologia
Investigators
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Principal Investigator: Adriana Carbó García, Nurse Servicio Central de Anestesiología

Publications of Results:
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Responsible Party: Adriana Carbó García, Nurse, Servei Central d' Anestesiologia
ClinicalTrials.gov Identifier: NCT03578393     History of Changes
Other Study ID Numbers: IRV-2017-01
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adriana Carbó García, Servei Central d' Anestesiologia:
Preanesthetic visit

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders