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

NCT04229199 | Completed

• 1 other identifier: 18-534
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• children's age

  upon recruitment.

• children's gender

  upon recruitment.

• parent relationship status.

  upon recruitment.

Study Arms (2)

intervention group (IG)

EXPERIMENTAL

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

control group (CG)

NO INTERVENTION

Dyads assigned to the CG were provided only the standard practice on their day admission to the hospital.

Interventions

simulation BEHAVIORAL

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.

intervention group (IG)

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• diagnosed as having mental or psychological disorders.

Sponsors & Collaborators

• King Fahad Medical City: lead

Study Sites (1)

king Fahad Medical City

Riyadh, Central, 11525, Saudi Arabia

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Hussein A Battah, MSN

  King Fahad Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: data collectors were unaware of participants groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 18, 2020
• Study Start: October 23, 2018
• Primary Completion: August 27, 2019
• Study Completion: October 20, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)