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

NCT06279091 | Active Not Recruiting

• 1 other identifier: A0104023PP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Anxiety

Keywords

Dental anxiety; Parental anxiety; Breathing Exercises; Bubble Blower Breathing; Diaphragmatic Breathing; Relaxation; Distruction

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

tell show do technique

EXPERIMENTAL

apply normal treatment with basic behavioral technique as a control group.

Behavioral: Tell Show Do

Diaphragmatic breathing technique

EXPERIMENTAL

apply normal treatment with breathing exercises as relaxation and distruction technique to reduce the dental anxiety.

Behavioral: Diaphragmatic Breathing

Bubble Blower breathing technique

EXPERIMENTAL

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

Interventions

Diaphragmatic Breathing BEHAVIORAL

apply breathing exercises to evaluate the effectiveness on anxiety reduction

Diaphragmatic breathing technique

Bubble Blower Breathing BEHAVIORAL

apply breathing exercises by using bubble blower to evaluate the effectiveness on anxiety reduction

Bubble Blower breathing technique

Tell Show Do BEHAVIORAL

apply basic behavioral management technique as control group

tell show do technique

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Use of analgesics before treatment.
• Presenting with acute pain and requiring emergency dental treatment.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Officials

• Alaa M Albakr, Master

  Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Selected children will be divided randomly into 3 groups: Control group (Group I). Diaphragmatic Breathing group (Group II). Bubble Blower Breathing group (Group III).

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 26, 2024
• Study Start: May 23, 2023
• Primary Completion: November 5, 2023
• Study Completion: May 23, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: within 6 month
• Access Criteria: for any one

Locations

EG (1)