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CompletedNCT06459089Updated Sep 20, 2024

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

An observational study in Perioperative Anxiety and Emergence Delirium, sponsored by Karaman Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by Karaman Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
5 Years to 12 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Perioperative Anxiety
  • Emergence Delirium

Keywords

  • Anxiety State
  • Familiar Toy
  • Child Behavior
03

In context

Emergence Delirium

763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.

This study's enrollment of 100 is below the median of 164 across 280 observational studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Karaman Training and Research Hospital is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Group1

    The children will select the parent who acoompany theim during anesthesia induction

    Behavioral: Selection of the parent according to children preference

  • 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 · Behavioral: Bringing the favorite toy of the children that will accompany the child during their perioperative period

Interventions

  • BehavioralSelection of the parent according to children preference

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

  • BehavioralBringing 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Perioperative period

Secondary outcomes

  1. 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

    Time frame: Postoperative 1st day

07

Study locations

1 site
  • Karaman Training and Research Hospital
    Karaman, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06459089
Lead sponsor
Karaman Training and Research Hospital
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
Jun 26, 2024
Primary completion
Sep 18, 2024
Completion
Sep 18, 2024
Last update
Sep 20, 2024

Study contacts

Ayşe Duran, MD
principal investigator · Karaman Training and Research Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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