Clinical trial NCT06634680: Effects of Different Parental Involvement on Anxiety and Delirium
Official title: Effects of Different Parental Involvement on Anxiety and Delirium in Children Undergoing Elective ENT Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety State
Child Behavior
Keywords: anxiety
children
anesthesia,general
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-10-10
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 surgery in the otorhinolaryngology clinic

Brief summary: Induction of anesthesia in surgical procedures can be a distressing process for both children and their parents. Nonpharmacological behavioral interventions, unlike sedative medications, can reduce children's anxiety without adverse effects. The effect of having both parents present during anesthesia induction on children's anxiety and parents' anxiety has not yet been documented.

This study will aim to evaluate the effect of having both parents present during anesthesia induction on children's and parental anxiety during the perioperative period.

Detailed description: Surgery can be very stressful for patients, especially children. Studies show that 50-75% of children experience fear and anxiety when undergoing surgery and being put under anesthesia. This anxiety can have adverse effects on their recovery, leading to more extended hospital stays, increased pain, and behavioral issues. To address this, various medical and non-medical approaches are used to ease children's fears. One such approach is allowing parents to be with their children until the anesthesia takes effect. This study aims to assess how having both parents present during this time impacts the child's anxiety levels.

The effect of parental presence on the anxiety of children and parents was studied in various studies. Whether both parents affect anxiety has not been studied yet. In this study the investigators will evaluate the anxiety of children by using mYPAS.

Eligibility criteria: Inclusion Criteria:

* 80 children of both sex, aged 5-12 years with ASA physical Status I-II will be enrolled

Exclusion Criteria:

* Mentally challenged
* Deaf Child
* Cerebral Palsy
* Premedicated Child
* Language Problem
* Uncooperative
* History of psychiatric disease in children or the parents
* Previous surgery or anesthesia history

Primary outcomes:
measure: Patients anxiety-Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.
timeFrame: Perioperative period
Secondary outcomes:
measure: Emergence delirium-Pediatric Anesthesia Emergence Delirium Scale (PAEDS)
timeFrame: Perioperative period
measure: Parent anxiety-STAI
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Rafet YARIMOGLU
Study officials:
affiliation: Karaman Training and Research Hospital
name: Rafet YARIMOGLU
role: PRINCIPAL_INVESTIGATOR
References: