To Assess Breathing Exercise as a Relaxation Method

NCT06698523 | Completed DMC

• 1 other identifier: PED23-4M
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Anxiety

Keywords

breathing exercise; play toys; heart rate; venham picture test; salivary alpha amylase

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  during dental treatment that will take 15-30 minutes

Study Arms (3)

Tell- show-Do

NO INTERVENTION

Control group

Bubble-blower

EXPERIMENTAL

breathing exercise technique using bubble-blower

Behavioral: Breathing exercise

Pin-wheel

EXPERIMENTAL

breathing exercise technique using Pin-wheel

Behavioral: Deep breathing

Interventions

Breathing exercise BEHAVIORAL

bubble blower used as play toys to facilitate the breathing exercise

Also known as: bubble blower exercise

Bubble-blower

Deep breathing BEHAVIORAL

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

Pin-wheel

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Faculty of Dentistry

Cairo, Egypt

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Passant Elbahy

  Ain Shams University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 21, 2024
• Study Start: July 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)