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Respiratory Biofeedback Device and Reduction of Dental Anxiety Associated With Local Anesthesia in Children

NCT04238312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-08-20

No results posted yet for this study

Summary

The aim of the study was to investigate the effect of a respiratory biofeedback device (RESPeRATE TM) in reduction of preoperative anxiety in children undergoing dental procedures under local anesthesia.

Conditions

Interventions

DEVICE

RESPeRATE™

Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.

BEHAVIORAL

Tell, Show and Do technique

Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • Sarah Zeitoun, M.Sc · Faculty of Dentistry, Alexandria University, Egypt

  • Amani Khalil, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Nadia Wahba, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Mohamed IS Ahmed, PhD · Faculty of Medicine, Alexandria University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2019-10-18
Completion
2020-01-15

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04238312 on ClinicalTrials.gov