Dental Anxiety
Conditions
Keywords
Dental anxiety, Nitrous Oxide
Brief summary
Dental anxiety (DA) is highly prevalent among children undergoing dental procedures, with 50-80% experiencing fear that disrupts treatment and exacerbates oral health outcomes. While nitrous oxide (N₂O) sedation is widely used for its anxiolytic properties, evidence remains limited regarding its standardized efficacy in reducing pediatric fear and anxiety scores.
Detailed description
This study adopted a randomized controlled trial (RCT) design, strictly adhering to the CONSORT (Consolidated Standards of Reporting Trials) guidelines to ensure scientific rigor, reliability, and transparency.The sample size was calculated based on previous literature and preliminary pilot study results. Referring to the standard deviations of dental fear and anxiety scores in similar studies, the significance level (α) was set at 0.05, and the power (1 - β) was set at 0.85 (90% power). With an effect size of 0.4, the study anticipated significant differences in fear and anxiety scores between the experimental and control groups. Using statistical formulas and considering practical constraints, the estimated sample size required for each group was no fewer than 58 participants to ensure sufficient statistical power.
Interventions
DRUGNitrous Oxide Sedation
After the child was seated in the dental chair, an appropriately sized nasal mask was selected to ensure a secure fit without leakage. The child initially inhaled 100% oxygen for 3-5 minutes to adapt to the breathing pattern and eliminate nitrogen from the lungs. Nitrous oxide was then introduced at an initial concentration of 10%-15%, with adjustments made in increments of 5%-10% based on the child's anxiety level, treatment stimuli, and vital signs. Each adjustment was followed by 1-2 minutes of observation until the desired level of sedation was achieved.
BEHAVIORALpsychological support
gentle communication, encouraging gestures, and distraction techniques such as soothing music or storytelling to help the child relax and cooperate.
Sponsors
Shaoxing Maternity and Child Health Care Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* 1.Aged 6-10 years; 2.Classified as American Society of Anesthesiologists (ASA) physical status I-II; 3.Required dental treatments such as caries filling, pulp therapy, or tooth extraction; 4.Informed consent obtained from the child's guardian.
Exclusion criteria
* 1.Contraindications to nitrous oxide inhalation, such as severe cardiopulmonary dysfunction, intestinal obstruction, or pneumothorax; 2.Mental illness or intellectual disability that would hinder cooperation with assessments or treatment; 3.Received dental sedation or general anesthesia within the past month;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDAS | From enrollment to the end of treatment at 1 week | The Modified Dental Anxiety Scale, zero is equivalent to no anxiety and 5 indicates the worst possible anxiety, participants achieved a response if they scored a performance status of 0 on a scale ranging from 0 (best outcome) to 5 (worst outcome) |
| Behavioral Observation Scale | From enrollment to the end of treatment at 1 week | The Frankl behavior rating scale was used to assess the children's behavior during treatment. This 4-point scale categorizes behavior , participants achieved a response if they scored a performance status of 1 on a scale ranging from 1 (best outcome) to 4 (worst outcome) |
| CFSS-DS | From enrollment to the end of treatment at 1 week | Children's Fear Survey Schedule-Dental Subscale, participants achieved a response if they scored a performance status of 1 on a scale ranging from 1 (best outcome) to 5 (worst outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HR | immediately after the intervention | heart rate |
| BP | systolic and diastolic will be assessed immediately after the intervention | blood pressure |
| RR | immediately after the intervention | respiratory rate |
Countries
China
Outcome results
None listed