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NCT Number: NCT06459089

The Effects of Familiar Toy and Parental Presence Combination on Perioperative Pediatric Anxiety

This study will evaluate the effect of presence of favorite toy and parent during perioperative period on pediatric anxiety and emergence delirium. Half of the patients patients will be accompanied with their ownselected parent and the other half will be accompanied with their favorite toy in addition to their own selected parent.

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Key information

Conditions

Perioperative Anxiety 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 Signs and Symptoms

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

About this study

To reduce the incidence of preoperative anxiety in children, anesthesiologists have used a number of prevention strategies, including sedative premedication, parental presence during anesthetic induction, behavioral preparation programs, music therapy, hypnosis, and acupuncture.One of these distraction tool is familiar toy, children may also be comforted by familiar toys. Therefore, parent presence during perioperative period or playing with a favorite toy seems likely to alleviate preoperative anxiety in children. Until now, combination of these two method to reduce anxiety is not observed in literature. Then, the aim of this observational study is to evaluate the effect of both presence of favorite toy and parental presence compare to only parental presence during perioperative period on anxiety and emergence delirium in patients undergoing ambulatory surgery in our hospital's otorhinolaryngology department.

Who can participate

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

Inclusion criteria

Patients with ASA 1 and 2, Those who have the ability to speak and obey commands will be included.

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 the parent according to children preference

Behavioral

The children will select the parent who will accompany them during the anesthesia induction

Bringing the favorite toy of the children that will accompany the child during their perioperative period

Behavioral

The children will bring tiheir favorite toy that will accompany them during their perioperative period

Primary 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.

Secondary 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

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

The Effects of Familiar Toy and Parental Presence on Perioperative Pediatric Anxiety

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Sep 20, 2024

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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