Comparison of safety and effectiveness of Ylang- ylang flower (Cananga Odorata) essential oil in aromatherapy in reducing anxiety in 6-10 year old children in their first restorative treatment appointment- A Randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in pulse rate as an indicator for reduction in anxiety levels of the child (6-10 years old) in their first dental restorative appointment
研究概览
简要总结
AIM: To compare the safety and effectiveness of Ylang-Ylang flower essential oil and Lavender flower essential oil in aromatherapy in reducing dental anxiety in children.
OBJECTIVE: To evaluate the safety and effectiveness of lavender flower essential oil and Ylang-Ylang flower essential oil on reducing dental anxiety and then to compare the effect of both to evaluate if there is a difference.
PRIMARY HYPOTHESIS: There is a difference in reducing the dental anxiety on using Aromatherapy with Ylang-ylang flower essential oil and Lavender Flower essential oil in 6-10-year-old children before and during the first restorative Appointment
NULL HYPOTHESIS: There is no difference in reducing the dental anxiety on using Aromatherapy with Ylang-ylang flower essential oil and Lavender Flower essential oil in 6-10-year-old children before and during First Restorative Treatment Appointment
METHODOLOGY: 60 patients fulfilling the inclusion criteria will be selected for the study.
b) Allocation of the patients into the three groups will be done randomly through the lottery method.
GROUP I (20 children): children not subjected to aromatherapy
GROUP II (20 children): children subjected to aromatherapy using Lavender Flower (Lavandula angustifolia) essential oil
GROUP III (20 children): children subjected to aromatherapy using Ylang-ylang (Cananga odorata) flower essential oil
All the participants will be counselled for the restorative procedure using "tell, show, do†technique.
Inhalation Aromatherapy essential oils will be diluted: 1% dilution (1 drop per teaspoon of carrier oil ; 5-6 drops per ounce). Carrier oil will be jojoba oil. Every patient will have a fresh batch of diluted essential oil diffused in the room.
d) The essential oil aromatherapy diffuser will be on for 15 minutes before the patients enters the dental setup, after which it will be turned off. The patient will then be introduced to the dental environment and counselled using “tell-show-do†technique for approximately 5 minutes, after which the treatment will be started and completed in approximately 15 minutes.
e) In Group II, children will be subjected to Aromatherapy with Lavender Flower (Lavandula angustifolia) essential oil.
f) Group III children will be subjected to Aromatherapy with Ylang-Ylang flower (Cananga odorata) essential oil.
g) The anxiety levels in children of all the groups will be recorded at two different intervals:
· Before entering the dental setup
· During procedure while using aromatherapy in first restorative appointment treatment.
· Anxiety levels will be assessed using a facial image scale.
Pulse rate will be monitored using a pulse oximeter.
DATA ANALYSIS will be done as follows:
Descriptive quantitative data will be expressed in mean and standard deviation, respectively. Data normality=Shapiro-Wilk test. Inter-group comparison of means between 3 groups=one-way ANOVA test followed by post-hoc Tukey test for pairwise comparison. Intra-group comparison of means before and after completion of restorative procedure will be done with the help of paired-t test. Confidence interval=95% and probability of α error=5%. Power of study=80%. P<0.05 is considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal healthy, well-nourished children of age-group between 6 and 10 years.
- •Patients with prior parental consent.
- •Patients with prior assent.
- •Patients who require restorative procedures.
- •Patients who are undergoing dental treatment for the first time.
排除标准
- •Children with common cold.
- •Prior history of allergic reactions to the aromatics.
- •Impaired psychological development.
- •Systemic diseases.
- •History of an untoward experience in the medical set up due to any prevailing medical conditions.
- •Any physical or mentally handicapping conditions.
结局指标
主要结局
Reduction in pulse rate as an indicator for reduction in anxiety levels of the child (6-10 years old) in their first dental restorative appointment
时间窗: Pulse rate will be recorded: | 1. Before the beginning of the first dental restorative appointment | 2. During the first dental restorative appointment
次要结局
- Facial image scale score ( Anxiety rating scale) as a parameter for reduction in anxiety levels of the child (6-10 years old) in their first dental restorative appointment(Facial image scale score ( Anxiety rating scale)will be recorded :)
研究者
Dr Amol N Patil
SMBT Dental College and Hospital Amrutnagar Sangamner