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Effects of Different Parental Involvement on Anxiety and Delirium

Effects of Different Parental Involvement on Anxiety and Delirium in Children Undergoing Elective ENT Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06634680
Enrollment
80
Registered
2024-10-10
Start date
2024-10-15
Completion date
2024-12-12
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety State, Child Behavior

Keywords

anxiety, children, anesthesia,general

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.

Interventions

PROCEDUREProcedure: Selection of parent(mother or father) according to children preference

Children will choose the parent who will accompany them.

PROCEDUREProcedure: Both parents will accompany the children.

Both parents will accompany the children.

Sponsors

Karaman Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patients anxiety-Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.Perioperative periodThe mYPAS will be used to evaluate the anxiety level of children. The mYPAS is an observational measure of preoperative anxiety consisting of 27 items in 5 domains (activity, emotional expressivity, state of arousal, vocalization, and use of parents). The adjusted mYPAS total score ranges from 23.3 to 100, with higher scores indicating greater anxiety.

Secondary

MeasureTime frameDescription
Emergence delirium-Pediatric Anesthesia Emergence Delirium Scale (PAEDS)Perioperative periodPediatric Anaesthesia Emergence Delirium (PAED) scale consists of 5 criteria (eye contact, purposeful movement, awareness of environment, restlessness, inconsolability) that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The score changes 0-20. Scores above 10 indicate delirium, while scores below 10 indicate no delirium.
Parent anxiety-STAIPerioperative periodThe State-Trait Anxiety Inventory (STAI) was used to evaluate the anxiety level of the parents. The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: I am tense; I am worried and I feel calm; I feel secure. Trait anxiety items include: I worry too much over something that really doesn't matter and I am content; I am a steady person. All items are rated on a 4-point scale (e.g., from Almost Never to Almost Always). Higher scores indicate greater anxiety.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026