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Completed

NCT Number: NCT06698523

To Assess Breathing Exercise as a Relaxation Method

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

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Key information

Conditions

Dental Anxiety

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Faculty of Dentistry

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BREATHING EXERCISE

Behavioral

bubble blower used as play toys to facilitate the breathing exercise

Other names: bubble blower exercise

Deep Breathing

Behavioral

pin wheel used as a play toy for achievement of breathing exercise

Primary outcomes

  1. 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

  2. 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.

  3. 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

  1. Innovation of a new protocol in behavior management prior to painful dental procedure

    Time frame: during dental treatment that will take 15-30 minutes

    breathing exercise using play toys as behavior management

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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