Clinical AnxietyNCT02024594
Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry
A study testing Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral therapy in people with Clinical Anxiety and Clinical Cooperation, run by Mashhad University of Medical Sciences.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 36 to 78 monthsHealthy volunteers can take part
- Conditions the study is for
- Clinical Anxiety, Clinical Cooperation
- What is being tested?
- Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 78 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- current episodes of medications or drug therapy
- systemic or congenital disorders
- mental retardation
About this study
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.
- Conditions
- Clinical Anxiety, Clinical Cooperation
- Being tested
- Nitrous Oxide-Oxygen conscious sedation, cognitive-behavioral therapy
- Keywords
- Nitrous Oxide-Oxygen conscious sedation, Cognitive Behavioral Therapy, Children, Preschool, dental anxiety, Patient Cooperation
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous Oxide-Oxygen conscious sedationDrug
cognitive-behavioral therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Nitrous Oxide-Oxygen | Experimental | Children in this group were sedated by rapid induction method by means of Nitrous Oxide-Oxygen gas. Receives: Drug: Nitrous Oxide-Oxygen conscious sedation |
| cognitive-behavioral therapy | Experimental | 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. Receives: Behavioral: cognitive-behavioral therapy |
| control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in Clinical Anxiety and Cooperation scales.
The anxiety and cooperation differences between the two dental visits (second visits were done after 1 week) were compared within the three groups.
Measured: baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startOct 2009
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatemeh Mazhari, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024594
- Sponsor's protocol ID
- 88311
- Status last verified
- Dec 2013
- First submitted
- 27 Dec 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry
- ClinicalTrials.gov ID
- NCT02024594
- Acronym / sponsor ID
- 88311
- Conditions
- Clinical Anxiety, Clinical Cooperation
- Keywords
- Nitrous Oxide-Oxygen conscious sedation, Cognitive Behavioral Therapy, Children, Preschool, dental anxiety, Patient Cooperation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nitrous Oxide-Oxygen | Experimental | Drug: Nitrous Oxide-Oxygen conscious sedationChildren in this group were sedated by rapid induction method by means of Nitrous Oxide-Oxygen gas. |
| cognitive-behavioral therapy | Experimental | Behavioral: cognitive-behavioral therapyChildren in this group were asked to come to playroom before entering operation room. Modeling , Benson relaxation and positive self-talking were instructed to them. |
| control | No intervention | –No intervention |
Who may qualify
- Ages
- 36 to 78 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- current episodes of medications or drug therapy
- systemic or congenital disorders
- mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous Oxide-Oxygen conscious sedation | Drug | Nitrous Oxide-Oxygen |
| cognitive-behavioral therapy | Behavioural | cognitive-behavioral therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral therapy in people with Clinical Anxiety and Clinical Cooperation, run by Mashhad University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in Clinical Anxiety and Cooperation scales. (time frame: baseline and 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2013.