NCT06761833

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

December 23, 2024

Last Update Submit

January 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

single center observational study

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent Universty Adana Hospital

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mental DisordersAnxiety Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 7, 2025

Study Start

January 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations