CTRI/2023/11/060336尚未招募2/3 期
A comparative Study on effect of lavender oil and lemongrass oil on mental health and concentration in healthy individuals with academic stress
DrKSugirtha1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月5日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- DASS-21 – Depression anxiety stress scale
研究概览
简要总结
Introduction:
- Stress is an innate response of the body that may be either physical, mental, or emotional to an unforeseen event that occurs in the life of the individual.
- Academic life is one of the events in an individual’s life that may have different stressors.
- Contemporary literature suggests that university life is subjected to different stressors arising from academic pressure, social problems, and personal issues.
- It may also involve living away from the family which brings social isolation and adds to personal vulnerability.
- Negative mental health leads to decreased energy, difficulty thinking, concentrating, and making career decisions. Students are a pillar of the future in building an educated society.
Aromatherapy:
- Aromatherapy is the popular complementary therapy that uses essential oils (also known volatile oils) from parts of the plants for the improvement of physical, emotional and spiritual well-being.
- Lavender and lemongrass oil as an herbal remedy has been associated with anxiolytic properties.
- It was suggested that the anxiolytic and antidepressant effects could be associated with the suppression of the activity of the sympathetic nervous system and it is perceived as pleasant and displays a relaxing activity, it has been employed in aromatherapy in different therapeutic contexts.
Study design:
- A Comparative Pre-Post study design will be adopted for this study. All the eligible subjects will be divided into two groups, Lavender group and Lemongrass group.
- Group 1 will receive inhalation of Lavender oil for 10 minutes/day & Group 2 will receive inhalation of Lemongrass oil for 10 minutes/day for a period of 30 days.
- Assessments will be done before the intervention, 15th day and after the intervention of 30 days.
Sample size : (n=100)
Randomization and Blinding:
- Subjects will be randomly divided (1:1 ratio) into Lavender group and Lemongrass group.
- Allocation concealment will be done using SNOSE (Sequentially Numbered Opaque Sealed Envelope) technique.
- Subjects and investigators will not be blinded in the study.
Primary Outcome:
- DASS-21 – Depression anxiety stress scale
- PSQI – Pittsburgh sleep quality index
- SLCT – Six letter cancellation task
- DLST - Digit letter substitution test
Secondary Outcome:
- BP – Blood pressure
- HR - Heart rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 30.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects who are willing to participate in the study.
排除标准
- •Subjects with Generalized anxiety disorder Subjects with Major depressive disorder Women during Pregnancy & lactation Subjects with other co-morbidities Subjects with head injury & Migraine Subjects who are on Anti-Psychotic & Anti-epileptic medications Subjects with learning disability Subjects with developmental delay Subjects with ENT Disorders Subjects with claustrophobia.
结局指标
主要结局
DASS-21 – Depression anxiety stress scale
时间窗: 1st week | 3rd week | 6th week
PSQI – Pittsburgh sleep quality index
时间窗: 1st week | 3rd week | 6th week
SLCT – Six letter cancellation task
时间窗: 1st week | 3rd week | 6th week
DLST - Digit letter substitution test
时间窗: 1st week | 3rd week | 6th week
次要结局
- BP - Blood pressure(HR - Heart rate)
研究者
Dr K Sugirtha
International Institute of Yoga and Naturopathy Medical Sciences
研究点 (1)
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