Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry

December 27, 2013 updated by: Fatemeh Mazhari, Mashhad University of Medical Sciences
Visiting anxious and fearful children is an inevitable prospect of the daily work of every dentist who treats pediatric patients. Dentists have been using a wide variety of non-pharmacological and some pharmacologic techniques to assist them in the management of children with anxiety. One strategy which seems promising for pain control in stressful medical situations is teaching the child to use behavioral and cognitive coping skills or a combination of both techniques. An alternative technique to non-pharmacologic approaches in children being anxious and lacking in cooperative ability is sedative technique such as nitrous oxide conscious sedation. As there is lack of studies comparing conscious sedation and combinations of cognitive-behavioral strategies in eliminating children's uncooperative behaviors and dental anxiety, the aim of this study was to compare the effectiveness of inhalation sedation with Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral therapy to reduce dental anxiety in preschool children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between3 to 6.5 year of old
  • Presence of moderate to severe dental anxiety
  • Parents' acceptance to cooperate in sampling process and 2 sessions of dental treatment
  • Presence of at least one mandibular primary molar needed pulp treatment
  • positive dental history

Exclusion Criteria:

  • current episodes of medications or drug therapy
  • systemic or congenital disorders
  • mental retardation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
No intervention
Experimental: Nitrous Oxide-Oxygen
Children in this group were sedated by rapid induction method by means of Nitrous Oxide-Oxygen gas.
Drug: Nitrous Oxide-Oxygen conscious sedation
Experimental: cognitive-behavioral therapy
Children in this group were asked to come to playroom before entering operation room. Modeling , Benson relaxation and positive self-talking were instructed to them.
Behavioral: cognitive-behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in Clinical Anxiety and Cooperation scales.
Time Frame: baseline and 1 week
The anxiety and cooperation differences between the two dental visits (second visits were done after 1 week) were compared within the three groups.
baseline and 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 27, 2013

First Submitted That Met QC Criteria

December 27, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Estimate)

December 31, 2013

Last Update Submitted That Met QC Criteria

December 27, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 88311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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