Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children
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.


Options:
A: Arm Label: Hypnovel® (midazolam); Type: ACTIVE_COMPARATOR; Interventions: Drug: Midazolam oral intake | Arm Label: Electronic tab; Type: EXPERIMENTAL; Interventions: Procedure: electronic tab | Intervention Type: PROCEDURE; Name: electronic tab; Assigned to Arm(s): Electronic tab | Intervention Type: DRUG; Name: Midazolam oral intake; Assigned to Arm(s): Hypnovel® (midazolam)
B: Arm Label: Standard Care; Type: OTHER; Interventions: Other: vapocoolant | Arm Label: Buzzy; Type: EXPERIMENTAL; Interventions: Device: Buzzy | Intervention Type: DEVICE; Name: Buzzy; Assigned to Arm(s): Buzzy | Intervention Type: OTHER; Name: vapocoolant; Assigned to Arm(s): Standard Care
C: Arm Label: Standard technique; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard technique | Arm Label: Parent participation technique; Type: EXPERIMENTAL; Interventions: Behavioral: Parent participation technique | Intervention Type: BEHAVIORAL; Name: Standard technique; Assigned to Arm(s): Standard technique | Intervention Type: BEHAVIORAL; Name: Parent participation technique; Assigned to Arm(s): Parent participation technique
D: Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: info group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: info | Arm Label: smartphone group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: smartphone | Arm Label: smartphone and info group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: info, Behavioral: smartphone | Intervention Type: BEHAVIORAL; Name: info; Assigned to Arm(s): info group, smartphone and info group | Intervention Type: BEHAVIORAL; Name: smartphone; Assigned to Arm(s): smartphone and info group, smartphone group

Answer: D