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

NCT ID: NCT04229199

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2019-10-20

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

simulation

Intervention Type: 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.

control group (CG)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Fahad Medical City

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hussein A. Battah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hussein A Battah, MSN

Role: PRINCIPAL_INVESTIGATOR

King Fahad Medical City

Locations

king Fahad Medical City

Riyadh, Central, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

18-534

Identifier Type: -

Identifier Source: org_study_id