Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-29 @ 12:09 PM
Study NCT ID:
NCT06761833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2024-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Behavioral Changes in Children.
Sponsor:
Baskent University
Organization:
Study Overview
Official Title:
The Effect of Preoperative Anxiety on Postoperative Behavioral Changes in Children Receiving Dental Treatment Under General Anesthesia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: