Effects of Different Parental Involvement on Anxiety and Delirium

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

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.

Study Overview

• Status: Completed
• Conditions: Child Behavior; Anxiety State
• Intervention / Treatment: Procedure: Procedure: Selection of parent(mother or father) according to children preference; Procedure: Procedure: Both parents will accompany the children.

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Rafet YARIMOGLU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group Child Preference; The children will prefer parents (mother or father) who will accompany them in the preoperative holding area and at induction.	Procedure: Procedure: Selection of parent(mother or father) according to children preference; Children will choose the parent who will accompany them.
Group Both Parents; Both parents will accompany the child in the preoperative holding area and at induction.	Procedure: Procedure: Both parents will accompany the children.; Both parents will accompany the children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients anxiety-Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.	The 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.	Perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence delirium-Pediatric Anesthesia Emergence Delirium Scale (PAEDS)	Pediatric 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.	Perioperative period
Parent anxiety-STAI	The 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.	Perioperative period

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Principal Investigator: Rafet YARIMOGLU, Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): December 12, 2024
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: children; anxiety; anesthesia,general
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Anxiety Disorders
• Other Study ID Numbers: 04- 2024/15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No