Postoperative Behavioral Changes in Children.

The Effect of Preoperative Anxiety on Postoperative Behavioral Changes in Children Receiving Dental Treatment Under General Anesthesia

In children scheduled for dental treatment, negative thoughts can lead to anxiety and make them resistant to treatment techniques. In our prospective, single-center observational study, we aim to investigate preoperative anxiety and postoperative negative behaviors in children aged 3 to 12 years who are set to undergo general anesthesia for dental conditions and treatments.

Study Overview

• Status: Not yet recruiting
• Conditions: Behavior Problems; Pediatrics; Pediatric Pain and Anxiety

Detailed Description

The study will involve children aged 3 to 12 who have been classified under the American Society of Anesthesiologists (ASA) as I-II. These children, scheduled for dental treatment between January 2025 and January 2026 at Başkent University Adana's Turgut Noyan Practice and Research Hospital, will undergo elective surgery under general anesthesia. Parental consent will be obtained prior to their inclusion in the research.

The assessment of preoperative anxiety levels in patients will be conducted using the Modified Yale Preoperative Anxiety Scale (m-YPAS). This evaluation will take place in the presence of their families within the anesthesia outpatient clinic and the preoperative preparation room on the day of surgery. The m-YPAS is structured into five categories: Activity, Speech, Emotional State, Awaking State, and Parent-Related Reactions, comprising a total of 22 items. The scoring for the Modified Yale Preoperative Anxiety Scale ranges from 5 to 22 points, with each item assigned a single point. Research has demonstrated that the Turkish validation of the m-YPAS is a valid and reliable tool for assessing preoperative anxiety in children aged 5 to 12 years.

Induction of general anesthesia will be standardized for all patients. The Bispectral Index (BIS) will be kept between 40- 60. All patients will receive standard local anesthetic by the pedodontist during the operation. The anesthesia physician will evaluate delirium using the Pediatric Postoperative Delirium Scale (PAED) at 1 minute post-surgery and every 10 minutes thereafter until the patient is transferred to the ward. The PAED scale has been used in Turkish studies to assess postoperative delirium. İn the absence of complications during the patient's follow-up in the ward, the patient will be discharged on the same day. To evaluate behavioral changes in children during the preoperative period, parents will be provided with information regarding the 11 item Post-Hospital Discharge Behavior Questionnaire ( PHBQ-AS) in the outpatient clinic. Parents will be requested to compare their children's behavior prior to hospitalization with their behavior following discharge for each item on the questionnaire. Additionally, follow-up phone calls will be conducted on the 2nd, 15th, and 30th days after discharge to collect and record survey results.

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey
    • Baskent Universty Adana Hospital
    • Contact: Emine KILINC, MD; Phone Number: +903224586868; Email: emine_98@hotmail.com
    • Principal Investigator: Emine KILINC, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients between the ages of 3 and 12 who are scheduled to receive dental treatment under general anesthesia.

Description

Inclusion Criteria:

1. Patients categorized as American Society of Anesthesiologists (ASA) groups 1 and 2.
2. Children aged 3 to 12 years who are scheduled to receive dental treatment under general anesthesia.

Exclusion Criteria:

1. The child patient or parent has a diagnosed psychiatric disorder.
2. There is a history of substance use that may affect cognitive function.
3. The parent has declined to participate in the study.
4. The child patient or parent does not speak Turkish.
5. Patients categorized as American Society of Anesthesiologists (ASA) group 3 and 4.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
single center observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of preoperative anxiety level on postoperative behavioral changes in children receiving dental treatment under general anesthesia.	This observational study, conducted at a single center, aims to investigate the occurrence of negative postoperative behavior in children	one year

Collaborators and Investigators

• Sponsor: Baskent University
• Collaborators: Baskent Univeristy Adana Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: BaskentU-EKILINC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No