Clinical trial NCT05931770: The Effect of Child Choice With Accompanying Parent on Postoperative Delirium During Induction of Anesthesia
Official title: The Effect of Child Choice With Accompanying Parent on Pediatric Anxiety and Postoperative Delirium During Induction of Anesthesia During Day Case Surgeries.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety State
Child Behavior
Postoperative Delirium
Keywords: day- case surgery, anxiety children
Postoperative Delirium
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 80 children of both genders, aged 5-12 years, who underwent day-case surgeries in the Ear Nose and Throat Clinic with ASA physical Status I-II will be enrolled

Brief summary: Induction of anesthesia can be distressing both for children and their parents. Nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs.

The aim of this study will be to evaluate whether the children's or parental preference with attending parent affects on the postoperative delirium of the children or not. The delirium of the children will be assessed by the Pediatric Anesthesia Occurrence Delirium Scale (PAED)

Detailed description: Anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety. . To minimize the effect of anxiety, several methods have been adopted, such as the introduction of day-case surgery, parental presence at the induction of anesthesia, distractions and the use of pharmacological agents like midazolam to reduce anxiety. Although the effect of parental presence on the anxiety of children and parents was studied in various studies. Whether the children's choice of parental selection affects anxiety and postoperative delirium not studied yet. In this study, we will evaluate the anxiety of children by using mYPAS and postoperative delirium by using PAED.

Eligibility criteria: Inclusion Criteria:

1. 5-12 years aged children
2. ASA physical Status I-II
3. Who underwent day-case surgeries in the Ear Nose and Throat Clinic

Exclusion Criteria:

1. Mentally challenged
2. Deaf Child
3. Cerebral Palsy
4. Premedicated Child
5. Language Problem
6. Unco-operative
7. Previous surgery or anesthesia history

Primary outcomes:
measure: Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room
timeFrame: Postoperative 1st day
Secondary outcomes:
measure: Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Fatih Yücedağ, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References: