The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anaesthetic Administration: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- Anxiety
研究概览
简要总结
Aim of the study To evaluate the effectiveness of sweet orange oil inhalation in reducing dental anxiety and pain in children undergoing local anaesthetic administration.
详细描述
Research Question:
Can sweet orange oil help to overcome dental anxiety and pain in children undergoing local anaesthetic administration?
PICO approach:
- P: Children 8 to 12 years old need dental treatment under local anesthesia.
- I: Sweet Orange oil inhalation.
- C: Without aromatherapy.
- O:
Primary Outcome Dental Anxiety Modified Child Dental Anxiety Scale - Faces version [MCDAS(f)-simplified] Pulse rate
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 (Participant, Investigator)
盲法说明
Blinding of the operator and the patients will not be feasible due to the difference between the used techniques. However, the statistician will be blinded.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Children classified with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.
- •Children aged 8-12 years.
- •Patients who need maxillary infiltration anaesthesia in the first dental visit.
排除标准
- •Children with any neurological or psychological disorders.
- •Children with previous LA administration.
- •Presence of dental or medical emergency.
- •Presence of systemic disorders.
- •Chidren with common cold.
- •Children with known allergy to topical or local anesthetic agents.
- •Parental refusal for participation.
研究组 & 干预措施
Group A (sweet orange oil group)
Aromatherapy with inhalers will be carried out in an open clinical setting. Three drops of sweet orange oil will be dispensed into a cotton wick of the inhaler, The children will be asked to inhale the aroma from the inhalers for 2 minutes followed by an induction period of 15 minutes.
干预措施: sweet orange oil inhalation (Other)
For Group B (Control Group)
No aromatherapy inhalation
结局指标
主要结局
Anxiety
时间窗: Through study completion , within 10 months
Pulse rate
次要结局
- Dental pain(Through study completion , within 10 months)
研究者
Shaimaa Abdel Azim Abdel Wahab
Princupal investigator /shaimaa Abdelazim
Cairo University