Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Anxiety
• Intervention / Treatment: Behavioral: Tell Show Do; Behavioral: Diaphragmatic Breathing; Behavioral: Bubble Blower Breathing

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Mansura university

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tell show do technique; apply normal treatment with basic behavioral technique as a control group.	Behavioral: Tell Show Do; apply basic behavioral management technique as control group
Experimental: Diaphragmatic breathing technique; apply normal treatment with breathing exercises as relaxation and distruction technique to reduce the dental anxiety.	Behavioral: Diaphragmatic Breathing; apply breathing exercises to evaluate the effectiveness on anxiety reduction
Experimental: Bubble Blower breathing technique; apply normal treatment with breathing exercises by bubbleblower which is a play therapy as relaxation and distruction technique to reduce the dental anxiety.	Behavioral: Bubble Blower Breathing; apply breathing exercises by using bubble blower to evaluate the effectiveness on anxiety reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
scale of dental anxiety by Pulse Oximeter	To measure heart rate	up to 12 weeks

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Salwa M Awad, prof, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University; Study Director: Rizk A Elagamy, PhD, Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University; Principal Investigator: Alaa M Albakr, Master, Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): November 5, 2023
• Study Completion (Estimated): May 23, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Relaxation; Parental anxiety; Diaphragmatic Breathing; Breathing Exercises; Dental anxiety; Bubble Blower Breathing; Distruction
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Anxiety Disorders
• Other Study ID Numbers: A0104023PP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol to other Researchers
• IPD Sharing Time Frame: within 6 month
• IPD Sharing Access Criteria: for any one
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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