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Completed

NCT Number: NCT04238312

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

The study was a randomized controlled clinical trial. A total of 110 anxious pediatric dental patients, of age range 7-12 years, were selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt, after securing parental informed consents. Children were chosen according to the Faces version of Modified Child Dental Anxiety Scale scoring 26 or more.

The participants will be randomly allocated into 2 groups: Group I: Study group and Group II: Control group. The patients of group I (Study group) will undergo a session of biofeedback regulation by using "RESPeRATETM" as an anxiety reducing method. Group II patients will be managed by a routine behavioral management technique "Tell,show,do". Local anesthesia injection will be administered to the child, after which heart rate measurement and salivary sample for salivary amylase analysis will be repeated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Normal healthy children (physical status ASA I & II).
  • Scoring 26 or more on faces version of modified child dental anxiety scale (MCDASf).
  • Dental procedure requiring local anesthesia.
  • Completion of a parental consent to participate in the study.

Exclusion criteria

  • Children on anxiolytic medication or using any medication directly related to emotional or cognitive function.
  • Children with special needs.
  • Children on medications that specifically agonize or antagonize alpha- or beta-adrenergic processes.

Treatment and study plan

RESPeRATE™

Device

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

Tell, Show and Do technique

Behavioral

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

Primary outcomes

  1. Heart Rate

    Time frame: baseline

    A finger pulse oximeter will be placed on the finger of the left hand of the child.

  2. Heart Rate

    Time frame: after 5 minutes

    A finger pulse oximeter will be placed on the finger of the left hand of the child.

  3. Oxygen saturation

    Time frame: baseline

    Oxygen saturation will be monitored using an oximeter

  4. Oxygen saturation

    Time frame: after 5 minutes

    Oxygen saturation will be monitored using an oximeter

  5. Behavior Evaluation

    Time frame: baseline

    using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive

  6. Behavior Evaluation

    Time frame: after 1 week during follow-up sessions

    using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

The Effect of a Respiratory Biofeedback Device on Reduction of Dental Anxiety Associated With Local Anesthesia in Children: A Randomized Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 23, 2020
Registry last updated
Aug 20, 2020

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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