Effects of Different Parental Involvement on Anxiety and Delirium

NCT06634680 | Completed

• 1 other identifier: 04- 2024/15
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Induction of anesthesia in surgical procedures can be a distressing process for both children and their parents. Nonpharmacological behavioral interventions, unlike sedative medications, can reduce children's anxiety without adverse effects. The effect of having both parents present during anesthesia induction on children's anxiety and parents' anxiety has not yet been documented. This study will aim to evaluate the effect of having both parents present during anesthesia induction on children's and parental anxiety during the perioperative period.

Conditions

Anxiety State; Child Behavior

Keywords

anxiety; children; anesthesia,general

Outcome Measures

Primary Outcomes (1)

• Patients anxiety-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 23.3 to 100, with higher scores indicating greater anxiety.

  Perioperative period

Secondary Outcomes (2)

• Emergence delirium-Pediatric Anesthesia Emergence Delirium Scale (PAEDS)

  Perioperative period

• Parent anxiety-STAI

  Perioperative period

Study Arms (2)

Group Child Preference

The children will prefer parents (mother or father) who will accompany them in the preoperative holding area and at induction.

Procedure: Procedure: Selection of parent(mother or father) according to children preference

Group Both Parents

Both parents will accompany the child in the preoperative holding area and at induction.

Procedure: Procedure: Both parents will accompany the children.

Interventions

Procedure: Selection of parent(mother or father) according to children preference PROCEDURE

Children will choose the parent who will accompany them.

Group Child Preference

Procedure: Both parents will accompany the children. PROCEDURE

Both parents will accompany the children.

Group Both Parents

Eligibility Criteria

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

Study Population

The study included 80 children of both genders, aged 5-12 years, who underwent day-case surgery in the otorhinolaryngology clinic

You may qualify if:

• children of both sex, aged 5-12 years with ASA physical Status I-II will be enrolled

You may not qualify if:

• Mentally challenged
• Deaf Child
• Cerebral Palsy
• Premedicated Child
• Language Problem
• Uncooperative
• History of psychiatric disease in children or the parents
• Previous surgery or anesthesia history

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Rafet YARIMOGLU

Karaman, Karaman, 70200, Turkey (Türkiye)

Location

Related Publications (1)

• Yarimoglu R, Sezgin A, Duran A, Yucedag F, Basaran B. The Impact of the Presence of Both Parents on Perioperative Anxiety in Children Undergoing Adenotonsillectomy Surgery: A Randomized Clinical Trial. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70167. doi: 10.1111/aas.70167.

  PMID: 41423202 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Child Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Rafet YARIMOGLU

  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: October 2, 2024
• First Posted: October 10, 2024
• Study Start: October 15, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-10

Locations

TU (1)