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.
|
|
|
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.
|
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.
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.