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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06279091
Other study ID # A0104023PP
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 23, 2023
Est. completion date May 23, 2024

Study information

Verified date February 2024
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction.


Description:

This study evaluated The Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date May 23, 2024
Est. primary completion date November 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 8 Years
Eligibility Inclusion Criteria: - Children aged 5_8 years old. - Moderate or severe dental anxiety based on the (CDAS). - Good general health, free from any systemic diseases or psychological disorders. - Teeth indicated for restoration treatment under local anesthesia. - No allergy to anesthetic drugs Exclusion Criteria: - Use of analgesics before treatment. - Presenting with acute pain and requiring emergency dental treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Diaphragmatic Breathing
apply breathing exercises to evaluate the effectiveness on anxiety reduction
Bubble Blower Breathing
apply breathing exercises by using bubble blower to evaluate the effectiveness on anxiety reduction
Tell Show Do
apply basic behavioral management technique as control group

Locations

Country Name City State
Egypt Mansura University Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary scale of dental anxiety by Corah Dental Anxiety Scale (CDAS) The CDAS is composed of four questions, with each question offering five possible responses. These responses are rated on a scale from 1 (representing no anxiety) to 5 (indicating extreme anxiety). The total anxiety score, which ranges from 4 to 20, is calculated by summing the scores from these questions. This scale categorizes anxiety levels as low (CDAS 4-8), moderate (CDAS 9-12), and high anxiety (CDAS 13-20).
this scale used to evaluate correlation of children and parental anxiety.
up to 12 Weeks
Primary scale of dental anxiety by Facial Image Scale (FIS) It consists of a single item with five response options, represented by faces ranging from severely happy(1) to very sad (5). up to 12 Weeks
Primary scale of dental anxiety by Venham Clinical Anxiety Scale (VCAS) This scale rates anxiety levels on a scale from 0 to 5. A score of 0 indicates relaxation, smiling, willingness, and the ability to converse. On the other hand, a score of 5 represents general loud crying and an inability to engage in verbal communication or cope with the situation. up to 12 Weeks
Primary scale of dental anxiety by Pulse Oximeter To measure heart rate up to 12 weeks
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