Clinical trial NCT04229199: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2020-01-18
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: children's preoperative anxiety at holding area.
timeFrame: at holding area before pushing patients inside operating theater.
measure: children's preoperative anxiety inside operating theater.
timeFrame: immediately before anesthesia induction.
measure: parents' anxiety
timeFrame: during the procedure.
measure: change from baseline in children's heart rate (HR) as a somatic response to anxiety
timeFrame: two time-points, baseline measures of HR at holding area, and secondly inside the operating theater immediately before anesthesia induction.
measure: change from baseline in children's systolic blood pressure (SBP) as a somatic response to anxiety
timeFrame: two time-points, baseline measures of SBP at holding area, and secondly inside the operating theater immediately before anesthesia induction.
measure: parents' presence during anesthesia induction
timeFrame: at the time of anesthesia induction during the study period.
Secondary outcomes:
Other outcomes:
measure: children's age
timeFrame: upon recruitment.
measure: children's gender
timeFrame: upon recruitment.
measure: parent relationship status.
timeFrame: upon recruitment.
measure: history of previous anesthesia
timeFrame: upon recruitment.
Locations:
city: Riyadh
country: Saudi Arabia
facility: king Fahad Medical City
state: Central
Study officials:
affiliation: King Fahad Medical City
name: Hussein A Battah, MSN
role: PRINCIPAL_INVESTIGATOR
References: