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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229199
• Other study ID #: 18-534
• Status: Completed
• Phase: N/A
• Start date: October 23, 2018
• Est. completion date: October 20, 2019

Study information

• Verified date: January 2020
• Source: King Fahad Medical City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 20, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	king Fahad Medical City	Riyadh	Central

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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