To Assess Breathing Exercise as a Relaxation Method

Evaluation of Bubble-Blower Exercise and Pin-Wheel Exercise on Dental Anxiety in Children: A Randomized Controlled Trial

in this study investigator evaluate the effectiveness of breathing exercise using two different play toys in reducing dental anxiety.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety
• Intervention / Treatment: Behavioral: Breathing exercise; Behavioral: Deep breathing

Detailed Description

bubble blower and pin wheel are used to facilitate breathing exercise and to reduce dental anxiety hence more cooperation of participants during dental treatment

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• children that had been introduced to dental setting without receiving any dental treatment
• According to Corah 's dental anxiety scale children classified with score 19 or more
• No learning disability or psychological disorder or parental anxiety

Exclusion Criteria:

• children in emergency visit
• Allergy to anesthetic drugs
• Use of analgesic before treatment
• Teeth with necrotic pulp
• children whose parents refused to sign informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Tell- show-Do; Control group
Experimental: Bubble-blower; breathing exercise technique using bubble-blower	Behavioral: Breathing exercise; bubble blower used as play toys to facilitate the breathing exercise; Other Names: bubble blower exercise
Experimental: Pin-wheel; breathing exercise technique using Pin-wheel	Behavioral: Deep breathing; pin wheel used as a play toy for achievement of breathing exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate to assess child's dental anxiety	correlating participants anxiety to heart rate the higher the heart rate indicating the higher the anxiety level of patients	during dental treatment after local anesthetic injection. Heart rate is measured in beats/min measured twice, first before any dental treatment and measured a second time after 7-10 minutes after injection of local anesthesia
Venham picture test used to assess dental anxiety	score 0-8, it is an eight cards photos that are shown to children if child chooses the more anxious child in picture this is recorded as a score, the higher the score the more anxious the participants.	during dental treatment recorded before any treatment is done and after five minutes of injection of local anesthesia
Salivary Alpha amylase	collecting saliva sample for assessment of alpha amylase by ELISA test, saliva collected twice before and after injection of local anesthesia and correlating concentration to dental anxiety the higher the concentration of alpha amylase indicates more anxious children	before any dental treatment is done and 7-10 minutes after injection of local anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Innovation of a new protocol in behavior management prior to painful dental procedure	breathing exercise using play toys as behavior management	during dental treatment that will take 15-30 minutes

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Passant Elbahy, Ain Shams University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: heart rate; breathing exercise; salivary alpha amylase; play toys; venham picture test
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: PED23-4M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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