Clinical trial NCT06612398: Effect of a Preparation Video on Preoperative Anxiety in Children Undergoing Dental Treatment Under GA
Official title: Effect of a Preoperative Preparation Video on Preoperative Anxiety Among Children Undergoing Dental Treatment Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Anxiety
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2024-09-25
Enrollment: 84
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study investigated the effect of an animated preoperative preparation video in mitigating preoperative anxiety among children receiving comprehensive dental treatment under General Anesthesia (GA).

Detailed description: This randomised controlled trial, conducted at King Abdullah University Hospital (KAUH) over an eight-month period from February to October 2023, focused on children aged four to seven years undergoing comprehensive dental treatment under GA. Participants were randomly assigned to either the control group or the study group. Participants in the control group received the standard care provided upon arrival at the Day Case Unit (DCU) at KAUH, involving only a verbal explanation of the anaesthesia induction process. In contrast, on the night before the surgery, participants in the study group were presented with an animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home. Additionally, all parents watched the video alongside their children and provided positive comments on its content. The primary outcome assessed was the children's preoperative anxiety measured by modified Yale Preoperative Anxiety Scale (m-YPAS) and Visual Facial Anxiety Scale (VFAS), allowing for an evaluation of the intervention's impact.

Eligibility criteria: Inclusion Criteria:

* Children who are healthy, with American Society of Anesthesiologists (ASA) Grade 1 and 2 status.
* Age 4-7 years.
* Children undergoing GA for the first time who require comprehensive dental rehabilitation.

Exclusion Criteria:

* Presence of a systemic disease, as well as mental, cognitive, and intellectual disabilities.
* Presence of visual or auditory disability.
* Participants who refuse to answer subjective scales due to heightened anxiety levels.
* Participants with no access to internet services.
* Presence of active severe dental pain and/or facial abscess as it could affect the participant's state anxiety.

Primary outcomes:
measure: modified Yale Preoperative Anxiety Scale
timeFrame: 1 day
measure: Visual Facial Anxiety Scale
timeFrame: 1 day
Secondary outcomes:
measure: Face, Legs, Activity, Cry, Consolability scale
timeFrame: 1 day
measure: Pediatric Anesthesia Emergence Delirium scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Mawia Bataineh, Doctor
role: STUDY_CHAIR
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