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

Emergence Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459089
• Other study ID #: 01-2024/13
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: July 20, 2024

Study information

• Verified date: April 2024
• Source: Karaman Training and Research Hospital
• Contact: Ayse Duran
• Phone: 05385980090
• Email: drayseolmez42[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 20, 2024
• Est. primary completion date: July 20, 2024
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Emergence Delirium
• Perioperative Anxiety

Intervention

Behavioral:
• Selection of the parent according to children preference
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
The children will bring tiheir favorite toy that will accompany them during their perioperative period

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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