Can Lavender Oil Inhalation Help to Overcome Dental Anxiety and Pain in Children? A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Vital Sign Measurements - 1 (sistolic and diastolic blood pressure)
研究概览
简要总结
The purpose of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention.
详细描述
Lavender oil has sedative properties. Dental anxiety is one of the most common obstacles to dental care, especially for children ranges from 3% to 43% in different populations. To the best of our knowledge, this is the first study to investigate the use of lavender oil inhalation and to assess the correlation of anxiety and vital signs among children during a stressful surgical dental intervention. This study design was constructed according to the vital sign evaluations, anxiety and pain scores. Primary hypothesis was that of lavender oil inhalation prior to surgical dental interventions would affect vital signs and consequently reduce anxiety and perception of pain in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being between 6 and 12 years of age
- •children who are determined as Frankl 2, 3 or 4
- •intellectually sufficient to complete the anxiety scale
- •volunteer to take part in the study
- •whose parents were willing to participate into the study
排除标准
- •aged under 6
- •has cognitive, cooperation (i.ex. Frankl 1) or systemic problems
- •common allergies or dental pain
研究组 & 干预措施
Control group
No application prior to interventions. No lavender oil inhalation.
Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)
干预措施: Anxiety scale (Other)
Control group
No application prior to interventions. No lavender oil inhalation.
Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)
干预措施: Pain scale - 1 (Other)
Lavender oil group
100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to tooth extractions.
Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale 2 (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)
干预措施: Anxiety scale (Other)
Lavender oil group
100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to tooth extractions.
Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale 2 (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)
干预措施: Pain scale - 1 (Other)
Lavender oil group
100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to tooth extractions.
Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale 2 (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)
干预措施: Pain scale - 2 (Other)
Lavender oil group
100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to tooth extractions.
Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale 2 (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)
干预措施: Inhalation (Behavioral)
Control group
No application prior to interventions. No lavender oil inhalation.
Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)
干预措施: Pain scale - 2 (Other)
结局指标
主要结局
Vital Sign Measurements - 1 (sistolic and diastolic blood pressure)
时间窗: through study completion an average of 9 months
changes in systolic and diastolic blood pressure pre-operatively, intra-operatively, post-operatively
Vital Sign Measurements - 2 (heart rate)
时间窗: through study completion an average of 9 months
changes in heart rate pre-operatively, intra-operatively, post-operatively
Vital Sign Measurements - 3 (saturation)
时间窗: through study completion an average of 9 months
changes in saturation pre-operatively, intra-operatively, post-operatively
次要结局
- Anxiety Scale - Face Image Scale (FIS)(through study completion an average of 9 months)
- Pain Scale 1 - Face, Legs, Activity, Cry, Consolability (FLACC)(through study completion an average of 9 months)
- Pain Scale 2 - Wong Baker Pain Rating Scales (WBS)(through study completion an average of 9 months)
研究者
Nazife Begüm KARAN
Assistant Professor, DDS, PhD
Recep Tayyip Erdogan University Training and Research Hospital