Evaluation of the Stress Levels of Children and Their Parents

May 24, 2025 updated by: Didem Sakaryali Uyar, Baskent University

Evaluation Of The Impact Of Dental Rehabilitation Under General Anesthesia On The Stress Levels Of Children And Their Parents

The stress levels of the participating child and their parents were evaluated using saliva to measure the stress biomarkers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All of the dental treatments of the enrolled children were performed under general anesthesia. The stress biomarkers, such as alpha-amylase and cortisol levels, were measured from the participating child's saliva samples at pre-operative and post-operative. Additionally, the stress levels of the mothers were evaluated by questionnaires at the beginning of the study.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06490
        • Baskent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: The children

  • who did not allow their dental treatments to be completed using behavioral guidance techniques in the clinical environment.
  • who had no physical or psychosocial diseases were recruited Exclusion Criteria: The children
  • who were unable to give a saliva sample due to increased anxiety or inadequate saliva.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Enrolled children
All of the enrolled children have been followed for 1-month. Pre-operative and post-operative saliva samples have been collected from all participating children.
Other: Saliva collection
Pre-operative saliva collected before the full mouth treatment under general anesthesia while, post-operative saliva collected at 1-month follow-up after general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alpha-amylase
Time Frame: 1-month
salivary biomarker
1-month
cortisol
Time Frame: 1-month
salivary biomarker
1-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2021

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

May 18, 2025

First Submitted That Met QC Criteria

May 18, 2025

First Posted (Actual)

May 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 24, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KA20/82

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data presented in this study are available from the corresponding authors upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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