Clinical trial NCT02246062: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone on Anxiety of Children
Official title: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Parent-Child Relations
Keywords: Anxiety
Anesthesia
Evaluation
Preoperative care
Child
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 84
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: Introduction

Intense preoperative anxiety in children has been associated with difficulty in anesthetic induction. In addition, anxiety of relatives is a factor of great importance and influence on the preoperative anxiety levels of children and effectively contributes to the development of behavioral changes in postoperative period.

Distress before surgery has been associated with short- and long-term consequences, including risks of emergence delirium and maladaptive postoperative behaviors. Strategies to decrease children's anxiety can provide suitable induction and minimizes these risks.

It is estimated that 40% to 75% of children undergoing surgery experience significant fear and anxiety during the preoperative period3-5 Several authors suggest that children under 4 years of age are at greater risk for developing anxiety preoperatively.

Among the strategies for reducing the pediatric population anxiety, the non-pharmacological approaches through alternative therapies that act on the psychological aspects are as important as the pharmacological ones 9.

Currently, there is great motivation towards non-pharmacological interventions aimed at anxiety relief for children and their families, such as parental presence during induction of anesthesia (PPIA), educational programs to prepare the family, and written information on anesthetic procedure provided to relatives and/or children. This is due in part to the large growth in outpatient practice and increased participation and presence of parents during children's hospitalization, but also to the new institutional strategies that motivate a more humane medical practice. Furthermore, there have emerged efficient behavioral intervention programs that use toys, cartoons, video games and smartphones.

It has been suggested the intuitive and easeness of use, and popularity, of smartphones as a way to make children become absorbed by scrolling through its menus, playing and investigating its other functions, hence making the anesthesiologists' approach trouble-free.

Some authors showed that using smartphone application and other electronic devices as part of a behavioral intervention program for children, while taking into account individual characteristics, may be a simple and effective way to reduce preoperative anxiety.

Objectives The aim of this study is to determine whether the quality of information provided to relatives at the ward and playing with age appropriate smartphone application may have an impact on prevalence and level of child's anxiety in the operating room (OR) at the induction of anesthesia.

Method

After approval by the Research Ethics Committee of Irmandade da Santa Casa de São Paulo, an open randomized clinical trial should be conducted to compare the level of anxiety of children and their relatives, according to the quality of information and use or not of smartphone application received in the preanesthetic period.

Eighty-four children undergoing elective surgical procedures and their relatives will be randomly selected through the List Randomizer program (www.random.org) and allocated into four groups: control group (CG), in which the relative receive only conventional verbal information one day before the procedure at ward; informative group (IG), 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; smartphone group (SG), 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; smartphone and informative group (SIG) 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.

Developed by the author, the leaflet consists of 17 brief items, such as questions and answers, and provides information regarding the most frequently asked questions by the relatives, as observed in our clinical practice. The contents of this informative leaflet cover aspects of the specialty and practice of anesthesiology, such as suspension and use of medications, fasting, full stomach and refeeding after anesthesia, laboratory tests, anesthesia in children, types of anesthesia, risks, induction and recovery room, presence of parents, and how to contribute to a peaceful anesthesia in children.

Inclusion criteria are ASA physical status I, II and III, according to the classification of the American Society of Anesthesiologists (ASA), age between 4 and 8 years, undergoing minor-medium elective surgical procedures with an indication of general anesthesia, who shall not receive premedication and whose parents are not illiterate.

The exclusion criteria for children are psychomotor deficits, use of psychoactive drugs, hearing and visual impairment, previous surgery; and for relatives, the exclusion criteria are illness or mental disorder clinically recognized and decline to participate.

The study begins always in the ward (W), one day before the procedure, during preanesthesia evaluation and on the conventional provision of information about anesthesia. One of the researchers applies the observational m-YPAS scale for child and then the relatives are fully informed about the characteristic of the study and will be asked to sign the consent form. At the end of the preanesthetic evaluation (APA) the relatives of the IG and SIG groups receive an information leaflet.

At the day of the procedure, in the waiting room (WR) of surgical centers, before the child is taken to the operating room (OR), the child anxiety is assessed by m-YPAS scale. All groups will also answer a sociodemographic questionnaire and open statement for satisfaction about the information received. The children of the groups SG and SIG, before taken to the OR receive smartphones for playing, remaining always accompanied by the relatives until the end of induction. In the OR, all children undergo standard monitoring and, immediately before induction of anesthesia through conventional technique (either intravenous or inhalational), are re-evaluated using m-YPAS (OR time).

Level and prevalence of children's anxiety (m-YPAS), will be measured at three times: ward (W), waiting room (WR) and operating room (OR) immediately before induction. The observational m-YPAS was used as originally proposed by Kain et al. A partial score was given for each domain, based on the score observed by the researcher, divided by the number of categories in that domain. The score for each domain is added to the others and then multiplied by 20. Cut-off scores to classify patients are: without anxiety (23.4-30), with anxiety (\< 30).

For sample size calculation, it was considered that the prevalence of children's anxiety in the operating room is 75% 23 and that the proposed intervention is able to reduce it by 35% 15. Thus, the investigators propose to use α-error of 5%, β-error of 20%, and confidence interval of 95%, totaling 84 patients, 21 in each group.

Eligibility 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.

Primary outcomes:
measure: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.
timeFrame: 24 hours before surgery
Secondary outcomes:
Other outcomes:
measure: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.
timeFrame: Immediately before entering operation room
measure: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.
timeFrame: Immediately before induction of anesthesia
Locations:
city: São Paulo
country: Brazil
facility: Irmandade Santa Casa de Misericórdia de São Paulo
Study officials:
affiliation: Irmandade Santa Casa de Misericórdia de São Paulo
name: Ligia AS Mathias, PhD
role: STUDY_DIRECTOR
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