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Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone on Anxiety of Children

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ClinicalTrials.gov Identifier: NCT02246062
Recruitment Status : Completed
First Posted : September 22, 2014
Results First Posted : January 7, 2016
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Débora de Oliveira Cumino, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Brief Summary:

Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience. Among the strategies for reducing children's anxiety, non-pharmacological strategies are as important as the pharmacological ones, but their its validity is still controversial.

Objectives: The aim of this study is to verify if the information provided to relatives as well as and smartphone application provided to children interferes in prevalence and level of child preoperative anxiety.

Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical procedures and their relatives are randomly allocated into four groups: control group (CG) where the relative received conventional information about anesthesia; info group (IG), relative received an information leaflet about anesthesia; device group (DG), relative received only conventional verbal information and the child received smartphone application immediately before entering the operating room; device and info group (DIG) relative received a leaflet containing information and the child received smartphone application. Children's anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for prevalence and level of anxiety in the groups.


Condition or disease Intervention/treatment Phase
Anxiety State Parent-Child Relations Behavioral: info Behavioral: smartphone Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children
Study Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Control group
in which the relative receive only conventional verbal information one day before the procedure at ward.
Active Comparator: info group
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
Behavioral: info
the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.

Active Comparator: smartphone group
in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
Behavioral: smartphone
the child received smartphone application immediately before entering the operating room

Active Comparator: smartphone and info group
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
Behavioral: info
the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.

Behavioral: smartphone
the child received smartphone application immediately before entering the operating room




Primary Outcome Measures :
  1. Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS. [ Time Frame: 24 hours before surgery ]
    The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (< 30).


Other Outcome Measures:
  1. Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS. [ Time Frame: Immediately before entering operation room ]
    The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).

  2. Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS. [ Time Frame: Immediately before induction of anesthesia ]
    The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).



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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA physical status I, II and III a
  • age between 4 and 8 years
  • undergoing minor-medium elective surgical procedures
  • indication of general anesthesia
  • not receive premedication
  • parents are not illiterate.

Exclusion Criteria:

  • psychomotor deficits
  • use of psychoactive drugs
  • hearing and visual impairment
  • previous surgery
  • for relatives, illness or mental disorder clinically recognized and decline to participate.

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): NCT02246062


Locations
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Brazil
Irmandade Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil, 01221010
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Investigators
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Study Director: Ligia AS Mathias, PhD Irmandade Santa Casa de Misericórdia de São Paulo

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Débora de Oliveira Cumino, MSC, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT02246062     History of Changes
Other Study ID Numbers: 288.712
First Posted: September 22, 2014    Key Record Dates
Results First Posted: January 7, 2016
Last Update Posted: January 7, 2016
Last Verified: December 2015
Keywords provided by Débora de Oliveira Cumino, Faculdade de Ciências Médicas da Santa Casa de São Paulo:
Anxiety
Anesthesia
Evaluation
Preoperative care
Child
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs