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

NCT ID: NCT06459089

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-26
• Study Completion Date: 2024-09-18

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.

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.

Conditions

Perioperative Anxiety; Emergence Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group1

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

Selection of the parent according to children preference

Intervention Type: BEHAVIORAL

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.

Selection of the parent according to children preference

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Interventions

Selection of the parent according to children preference

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karaman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayşe Duran, MD

Role: PRINCIPAL_INVESTIGATOR

Karaman Training and Research Hospital

Locations

Karaman Training and Research Hospital

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

01-2024/13

Identifier Type: -

Identifier Source: org_study_id