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

The Effects of Familiar Toy and Parental Presence 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.

Study Overview

• Status: Completed
• Conditions: Emergence Delirium; Perioperative Anxiety
• Intervention / Treatment: Behavioral: Selection of the parent according to children preference; Behavioral: Bringing the favorite toy of the children that will accompany the child during their perioperative period

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Karaman, Turkey
    • Karaman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

100 child patients between the ages of 5-12 who will undergo ENT surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group1; The children will select the parent who acoompany theim during anesthesia induction	Behavioral: Selection of the parent according to children preference; The children will select the parent who will accompany them during the anesthesia induction
Group 2; The children will select the parent who accompany them dring anesthesia induction and bring their favorite toy also to the operating room.	Behavioral: Selection of the parent according to children preference; The children will select the parent who will accompany them during the anesthesia induction; Behavioral: Bringing the favorite toy of the children that will accompany the child during their perioperative period; The children will bring tiheir favorite toy that will accompany them during their perioperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 22.9 to 100, with higher scores indicating greater anxiety.	Perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room	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	Postoperative 1st day

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Principal Investigator: Ayşe Duran, MD, Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Actual): September 18, 2024
• Study Completion (Actual): September 18, 2024

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Child Behavior; Anxiety State; Familiar Toy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Anxiety Disorders; Emergence Delirium
• Other Study ID Numbers: 01-2024/13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No