Effectiveness of Preoperative Tour in Simulation Operating Theater in Reducing Preoperative Anxiety in Children

Effectiveness of Preoperative Tour in Simulation Operating Theater in Reducing Preoperative Anxiety in Children and Their Parents: A Pragmatic, Single-blinded, Randomized Controlled Trial

this study conducted to evaluate the effectiveness of preoperative tour to simulation operating theater on reducing children's and parents' preoperative anxiety. half of the participant were taken in a tour to a simulation operating theater before the day of operation and the other half were given the standard of care.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: simulation

Detailed Description

the investigators examined the effectiveness of a preoperative tour to a simulation operating theater guided by an expert anesthesia technologist on reducing the Preoperative anxiety levels for children who were scheduled for elective day case procedures under general anesthesia, and their parents' anxiety levels through a 10-months randomized controlled trial at tertiary medical center in Riyadh-Saudi Arabia, and confirmed that children and parents who received the intervention had significantly lower preoperative anxiety levels than controlled children and parents.

Given that, the results showed critical levels of preoperative anxiety among school age children, and that preoperative tour to simulation operating theater as a child-friendly maneuver is directly applicable and could be considered for children scheduled for day-case procedures under general anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Central
    • Riyadh, Central, Saudi Arabia, 11525
      • King Fahad Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children who were scheduled for elective day-case procedures under general anesthesia at KFMC.
• class 1 or 2 according to the American society of anesthesiology physical status.

Exclusion Criteria:

• diagnosed as having mental or psychological disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group (IG); Dyads of children and parents allocated to the IG were taken into a tour to a simulation operating room accompanied by an expert anesthesia technologist two weeks before the day of surgery. This simulation operating theater is a real operating room equipped with a surgical trolley, sealing surgical lights, anesthesia machine, vital signs monitor, stethoscope, surgical trays, surgical sink, and gas supply pendent. It was prepared with popular cartoon characters, child manikin, and face masks connected to the anesthesia circuit and re-breathing bag. After being assessed by anesthesia clinic doctors, children and their parents in the IG were given a chance to visit the simulation operating room, to receive orientation, education, and demonstration orientation about what they are going to experience in the operating room. Children were encouraged to apply vital signs monitoring, and to simulate providing mask anesthesia induction to a child manikin.	Behavioral: simulation; Dyads allocated to the IG were taken into a tour to a simulation operating room accompanied by an expert anesthesia technologist two weeks before the day of surgery. This simulation operating theater is a real operating room equipped with a surgical trolley, sealing surgical lights, anesthesia machine, vital signs monitor, stethoscope, surgical trays, surgical sink, and gas supply pendent. It was prepared with popular cartoon characters, child manikin, and face masks connected to the anesthesia circuit and re-breathing bag. After being assessed by anesthesia clinic doctors, children and their parents in the IG were given a chance to visit the simulation operating room, to receive orientation, education, and demonstration orientation about what they are going to experience in the operating room. Children were encouraged to apply vital signs monitoring, and to simulate providing mask anesthesia induction to a child manikin.
No Intervention: control group (CG); Dyads assigned to the CG were provided only the standard practice on their day admission to the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
children's preoperative anxiety at holding area.	measured using the modified-Yale Pre-Operative Anxiety Scale (m-YPAS). The m-YPAS is an observational anxiety scale used to assess anxiety levels in the preoperative period and during the induction of anesthesia. The total score of the scale ranged from 23 to 100, and the higher score means a worse outcome. The reference point to define high anxiety cases in the preoperative period is 30.	at holding area before pushing patients inside operating theater.
children's preoperative anxiety inside operating theater.	measured using the modified-Yale Pre-Operative Anxiety Scale (m-YPAS). The m-YPAS is an observational anxiety scale used to assess anxiety levels in the preoperative period and during the induction of anesthesia. The total score of the scale ranged from 23 to 100, and the higher score means a worse outcome. The reference point to define high anxiety cases in the preoperative period is 30.	immediately before anesthesia induction.
parents' anxiety	a self-administered questionnaire, Parents' anxiety was assessed using a validated version of Beck Anxiety Inventory Scale (BAIS) into Arabic. The total scale score range from 0 to 63, where a score of 0-9 indicates no anxiety, 10-18 mild anxiety, 19-29 moderate anxiety, and 30-63 severe anxiety.	during the procedure.
change from baseline in children's heart rate (HR) as a somatic response to anxiety	somatic signs of anxiety, including children's heart rate (HR) were recorded.	two time-points, baseline measures of HR at holding area, and secondly inside the operating theater immediately before anesthesia induction.
change from baseline in children's systolic blood pressure (SBP) as a somatic response to anxiety	somatic signs of anxiety, including children's systolic blood pressure (SBP) were recorded.	two time-points, baseline measures of SBP at holding area, and secondly inside the operating theater immediately before anesthesia induction.
parents' presence during anesthesia induction	the parents' attendance inside operating theater during anesthesia induction for their child, measured as (Yes or No).	at the time of anesthesia induction during the study period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
children's age	the age of child participants measured by years.	upon recruitment.
children's gender	the gender of child participants (male, female)	upon recruitment.
parent relationship status.	the child living with (parents, mother, father, others)	upon recruitment.
history of previous anesthesia	the child previous history of general anesthesia, measured as (Yes or No).	upon recruitment.

Collaborators and Investigators

• Sponsor: King Fahad Medical City
• Investigators: Principal Investigator: Hussein A Battah, MSN, King Fahad Medical City

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2018
• Primary Completion (Actual): August 27, 2019
• Study Completion (Actual): October 20, 2019

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 12, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 12, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 18-534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No