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Clinical Trials/NCT06698523
NCT06698523CompletedNot Applicable

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

Ain Shams University1 site in 1 country90 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
90
Locations
1
Primary Endpoint
Heart rate to assess child's dental anxiety

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Pin-wheel

Experimental

breathing exercise technique using Pin-wheel

Intervention: Deep breathing (Behavioral)

Tell- show-Do

No Intervention

Control group

Bubble-blower

Experimental

breathing exercise technique using bubble-blower

Intervention: Breathing exercise (Behavioral)

Outcomes

Primary Outcomes

Heart rate to assess child's dental anxiety

Time Frame: 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

correlating participants anxiety to heart rate the higher the heart rate indicating the higher the anxiety level of patients

Venham picture test used to assess dental anxiety

Time Frame: during dental treatment recorded before any treatment is done and after five minutes of injection of local anesthesia

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.

Salivary Alpha amylase

Time Frame: before any dental treatment is done and 7-10 minutes after injection of local anesthesia

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

Secondary Outcomes

  • Innovation of a new protocol in behavior management prior to painful dental procedure(during dental treatment that will take 15-30 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Passant Mohamed Ibrahim Attia Elbahy

Principal Investigator

Ain Shams University

Study Sites (1)

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