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

NCT ID: NCT02024594

Last Updated: 2013-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Clinical Anxiety Clinical Cooperation

Keywords

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Nitrous Oxide-Oxygen conscious sedation Cognitive Behavioral Therapy Children, Preschool dental anxiety Patient Cooperation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Nitrous Oxide-Oxygen

Children in this group were sedated by rapid induction method by means of Nitrous Oxide-Oxygen gas.

Group Type EXPERIMENTAL

Nitrous Oxide-Oxygen conscious sedation

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

cognitive-behavioral therapy

Intervention Type BEHAVIORAL

control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nitrous Oxide-Oxygen conscious sedation

Intervention Type DRUG

cognitive-behavioral therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

36 Months

Maximum Eligible Age

78 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Fatemeh Mazhari

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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88311

Identifier Type: -

Identifier Source: org_study_id