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

NCT06459089 | Completed DMC

• 1 other identifier: 01-2024/13
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perioperative Anxiety; Emergence Delirium

Keywords

Anxiety State; Familiar Toy; Child Behavior

Outcome Measures

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.

  Perioperative period

Secondary Outcomes (1)

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

  Postoperative 1st day

Study Arms (2)

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

Selection of the parent according to children preference BEHAVIORAL

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

Group 2; Group1

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

Group 2

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium; Anxiety Disorders; Child Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Ayşe Duran, MD

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: June 26, 2024
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

TU (1)