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NCT Number: NCT05931770

The Effect of Child Choice With Accompanying Parent on Postoperative Delirium During Induction of Anesthesia

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)

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Key information

Conditions

Anxiety State Anxiety Disorders Behavior Child Behavior Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium Signs and Symptoms

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Mentally challenged
  • Deaf Child
  • Cerebral Palsy
  • Premedicated Child
  • Language Problem
  • Unco-operative
  • Previous surgery or anesthesia history

Treatment and study plan

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

Procedure

The parent who will accompany the child during the perioperative period will be determined by the child. will be determined by children preference

Parent (mother or father) selection according to parents' preference

Procedure

Accompanying parentwho will accompany during the perioperative period will be determined by the parents. to be determined by

Primary outcomes

  1. Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room

    Time frame: Postoperative 1st day

    Incidence of post-anesthesia and postoperative delirium Discordant behaviors assessed with Pediatric Anesthesia Emergence Delirium Scale (PAED) with five features, each scored using a 5-point Likert scale

Secondary outcomes

  1. Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.

    Time frame: Perioperative period

    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 22.9 to 100, with higher scores indicating greater anxiety.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

The Effect of Child Choice With Accompanying Parent on Pediatric Anxiety and Postoperative Delirium During Induction of Anesthesia During Day Case Surgeries.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2023
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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