Back to resultsEffectiveness of Preoperative Tour in Simulation Operating Theater in Reducing Preoperative Anxiety in Children
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
simulation
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety
Eligibility Criteria
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.
Sites / Locations
- king Fahad Medical City
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group (IG)
control group (CG)
Arm Description
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.
Dyads assigned to the CG were provided only the standard practice on their day admission to the hospital.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
parents' presence during anesthesia induction
the parents' attendance inside operating theater during anesthesia induction for their child, measured as (Yes or No).
Secondary Outcome Measures
Full Information
NCT ID
NCT04229199
First Posted
January 2, 2020
Last Updated
January 12, 2020
Sponsor
King Fahad Medical City
1. Study Identification
Unique Protocol Identification Number
NCT04229199
Brief Title
Effectiveness of Preoperative Tour in Simulation Operating Theater in Reducing Preoperative Anxiety in Children
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
August 27, 2019 (Actual)
Study Completion Date
October 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Fahad Medical City
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Outcomes Assessor
Masking Description
data collectors were unaware of participants groups.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group (IG)
Arm Type
Experimental
Arm Description
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.
Arm Title
control group (CG)
Arm Type
No Intervention
Arm Description
Dyads assigned to the CG were provided only the standard practice on their day admission to the hospital.
Intervention Type
Behavioral
Intervention Name(s)
simulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
children's preoperative anxiety at holding area.
Description
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.
Time Frame
at holding area before pushing patients inside operating theater.
Title
children's preoperative anxiety inside operating theater.
Description
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.
Time Frame
immediately before anesthesia induction.
Title
parents' anxiety
Description
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.
Time Frame
during the procedure.
Title
change from baseline in children's heart rate (HR) as a somatic response to anxiety
Description
somatic signs of anxiety, including children's heart rate (HR) were recorded.
Time Frame
two time-points, baseline measures of HR at holding area, and secondly inside the operating theater immediately before anesthesia induction.
Title
change from baseline in children's systolic blood pressure (SBP) as a somatic response to anxiety
Description
somatic signs of anxiety, including children's systolic blood pressure (SBP) were recorded.
Time Frame
two time-points, baseline measures of SBP at holding area, and secondly inside the operating theater immediately before anesthesia induction.
Title
parents' presence during anesthesia induction
Description
the parents' attendance inside operating theater during anesthesia induction for their child, measured as (Yes or No).
Time Frame
at the time of anesthesia induction during the study period.
Other Pre-specified Outcome Measures:
Title
children's age
Description
the age of child participants measured by years.
Time Frame
upon recruitment.
Title
children's gender
Description
the gender of child participants (male, female)
Time Frame
upon recruitment.
Title
parent relationship status.
Description
the child living with (parents, mother, father, others)
Time Frame
upon recruitment.
Title
history of previous anesthesia
Description
the child previous history of general anesthesia, measured as (Yes or No).
Time Frame
upon recruitment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hussein A Battah, MSN
Organizational Affiliation
King Fahad Medical City
Official's Role
Principal Investigator
Facility Information:
Facility Name
king Fahad Medical City
City
Riyadh
State/Province
Central
ZIP/Postal Code
11525
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Preoperative Tour in Simulation Operating Theater in Reducing Preoperative Anxiety in Children
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